<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506840</url>
  </required_header>
  <id_info>
    <org_study_id>DPS.DGC.01.19</org_study_id>
    <nct_id>NCT04506840</nct_id>
  </id_info>
  <brief_title>Physical Activity and Motivation in Colorectal Cancer Patients</brief_title>
  <official_title>Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Miguel Hernandez de Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Puerta de Hierro University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministerio de Ciencia e Innovación, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Miguel Hernandez de Elche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intervention will be a physical exercise program for colorectal cancer patients during&#xD;
      the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the&#xD;
      treatment and improving patients' quality of life. In addition, the investigators try to&#xD;
      improve endurance and resistance training level, in order to achieve greater physical&#xD;
      functionality, survival and general well-being. For this, the investigators will carry out an&#xD;
      exercise program based mainly on muscular strength and cardiorespiratory condition. It will&#xD;
      last 6 months, with a frequency of 3 days per week, including sessions of 60 minutes.&#xD;
      Sessions will consist of three parts: warm-up, main part (endurance and resistance training),&#xD;
      and cool down. An individualized and supervised progression of training will take place. The&#xD;
      intensity levels will always be adjusted to the initial levels of the participants, always&#xD;
      considering their preferences and comfort.&#xD;
&#xD;
      Participants' preferences and exercise history will be considered through an initial&#xD;
      interview. Motivational strategies based on self-determination theory will be applied, since&#xD;
      it is one of the most used theories in the field of physical exercise. This theory proposes&#xD;
      that all people need to feel competent, autonomous and socially related. If these three needs&#xD;
      are satisfied, participants will develop more positive (autonomous) forms of motivation,&#xD;
      which are related to better consequences such as vitality, enjoyment, quality of life and&#xD;
      adherence to physical activity. In addition, motivational strategies will be applied for&#xD;
      families and healthcare professionals.&#xD;
&#xD;
      Before starting the program and at the end of it, each eligible patient will be evaluated&#xD;
      through:&#xD;
&#xD;
        -  Physical activity: strength test of lower and upper limbs, agility test, stress test for&#xD;
           cardiorespiratory fitness, physical activity levels, physical condition and body&#xD;
           composition.&#xD;
&#xD;
        -  Psychological factors: autonomy support, basic psychological need satisfaction,&#xD;
           motivation, quality of life, perceived barriers, depression, anxiety, hope, quality of&#xD;
           life.&#xD;
&#xD;
        -  Clinical parameters: survival rate, side effects, biological factors, treatment delays&#xD;
           and planned treatment completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and justification of the project In Spain, cancer is the second cause of death&#xD;
      after cardiovascular diseases. However, if it is divided by sex, cancer is the leading cause&#xD;
      of death for men and the second cause for women. In recent years there has been an increase&#xD;
      in new cases of cancer due to population growth and aging, since 2/3 of cancer patients are&#xD;
      older than 65 years. In addition to the impact of this disease on people's quality of life, a&#xD;
      high economic cost has been estimated for the health system. For example, the total cost of&#xD;
      cancer in 2015 in Spain was 7,168 million euros. This situation represents an important&#xD;
      public health problem and therefore implies that research on the factors that can prevent or&#xD;
      alleviate this disease should be considered as a priority.&#xD;
&#xD;
      In this regard, there is increasing scientific evidence of the physical and psychosocial&#xD;
      benefits of exercise both during and after the treatment of this disease. Nevertheless, only&#xD;
      30-40% of cancer survivors perform the necessary physical activity (PA) recommended by the&#xD;
      main medical institutions. In fact, a significant number of patients are obese (33%) and have&#xD;
      a low cardiorespiratory condition (45%). Despite this, PA continues to decrease after&#xD;
      diagnosis and only 5-10% of patients are physically active during treatment and 20-30% after&#xD;
      treatment. Therefore, the development of intervention programs aimed at promoting PA should&#xD;
      be a fundamental objective in the fight against cancer and its physical and psychosocial&#xD;
      consequences. In this line, our general objective will be to develop a motivation PA program&#xD;
      for colorectal cancer patients. Specifically, and considering the gaps existing in the&#xD;
      current literature, our general objective is subdivided into the following specific&#xD;
      objectives:&#xD;
&#xD;
        -  To evaluate the physical, psychosocial and behavioural effects, in the short and medium&#xD;
           term, of a physical exercise program in which motivational strategies based on&#xD;
           self-determination theory are applied.&#xD;
&#xD;
        -  To explore qualitatively the benefits of the physical exercise program, as well as the&#xD;
           troubles encountered in its implementation.&#xD;
&#xD;
        -  To develop an educational guide and an intervention protocol to encourage motivation and&#xD;
           adherence to PA of colorectal cancer patients.&#xD;
&#xD;
      Methodology This study will require a sample size of 34 patients. This calculation was made&#xD;
      through the G*power software, by means of an analysis of variance (ANOVA), adjusting the&#xD;
      values to p &lt;.05, with a statistical power of 80% and an effect size of 0.5. The patients&#xD;
      will be recently diagnosed with colorectal cancer in phases II-III by the oncology service of&#xD;
      the Hospital Universitario Puerta de Hierro de Majadahonda. Inclusion criteria include to be&#xD;
      between 18 and 75 years old, to be undergoing chemotherapy treatment, and to not have any&#xD;
      type of associated pathology that prevents them from performing PA. A intervention with an&#xD;
      experimental group and a control group will be conducted, where 17 patients will be assigned&#xD;
      to a control group, and 17 patients will perform a supervised motivational exercise program.&#xD;
&#xD;
      Measures Cardiorespiratory fitness. Stress tests adapted to the characteristics of the&#xD;
      patients will be performed, both in the type of ergometer and in the protocol. We will use&#xD;
      electrocardiographic recording and gas exchange analysis. Aerobic and anaerobic exercise&#xD;
      thresholds will be established.&#xD;
&#xD;
      Quality of life. The validated Spanish version of the EORTC-QLQ-CR30 will be used for&#xD;
      patients with colorectal cancer.&#xD;
&#xD;
      Body composition. Anthropometries will be carried out to estimate body composition&#xD;
      parameters.&#xD;
&#xD;
      Biological parameters. The usual analytics carried out in the hospital during the treatment&#xD;
      will be used to check the patient's health status and the side effects of the chemotherapy&#xD;
      treatment.&#xD;
&#xD;
      Anxiety. The validated version in Spanish of the Hamilton Anxiety Scale will be used.&#xD;
&#xD;
      Depression. The Spanish version of the Hamilton Depression Scale will be used. Autonomy&#xD;
      support. The Spanish version of the Perceived Autonomy Support for Exercise Settings will be&#xD;
      used.&#xD;
&#xD;
      Perceived barriers to do PA. This scale will be translated and validated to the Spanish&#xD;
      context.&#xD;
&#xD;
      Basic psychological needs in exercise. We will use the Basic Psychological Needs in Exercise&#xD;
      Scale.&#xD;
&#xD;
      Basic psychological needs in life. The Spanish version of the Basic Psychological Need&#xD;
      Satisfaction and Frustration Scale will be used.&#xD;
&#xD;
      Types of motivation. To measure motivation towards PA, the Behavioural Regulation in Exercise&#xD;
      Questionnaire will be for PA levels. The Spanish version of the IPAQ questionnaire will be&#xD;
      used. On the other hand, PA will be measured in a direct and objective way through portable&#xD;
      GT3X accelerometers.&#xD;
&#xD;
      Design, procedure and data analysis The intervention program will be carried out at the&#xD;
      Hospital Universitario Puerta de Hierro of Majadahonda. The program will last 6 months, with&#xD;
      three weekly one-hour sessions, and will comply with the recommendations established by the&#xD;
      American Cancer Society and the American College of Sports Medicine. The safety precautions&#xD;
      and contraindications identified by these institutions for colorectal cancer patients will be&#xD;
      especially considered. The program will include aerobic sessions at moderate and vigorous&#xD;
      intensities, as well as strength work. Patients will be monitored to model exercise loads&#xD;
      individually.&#xD;
&#xD;
      The measurements will be made just before starting the PA program (T1) in the case of the&#xD;
      experimental group, at an initial time of the equivalent treatment in the case of the control&#xD;
      group. The same measures will be carried out 6 months later (T2). For PA levels, instead of&#xD;
      measuring them just after the end of the program, we will wait another month so that patients&#xD;
      have been able to recover their usual PA levels after the shock that can mean for them to&#xD;
      face the end of our program. In the control group, PA levels will also be evaluated one month&#xD;
      after T2. To test the effects of the program, all measurements will be performed 6 months&#xD;
      after T2 in both groups (T3).&#xD;
&#xD;
      Additionally, qualitative methodology will be used, so that the 17 patients of the&#xD;
      experimental group will be interviewed to know the factors related to their adherence to the&#xD;
      PA program and the benefits perceived by them with their participation. Qualitative data&#xD;
      collection will be reinforced with field notes compiled in research diaries by observers who&#xD;
      will be present during the development of the program. Relatives and health professionals&#xD;
      will also be interviewed to learn their perspective regarding the benefits of the program and&#xD;
      adherence to it in these patients.&#xD;
&#xD;
      In order to promote adherence to the program and to educate in autonomous PA habits when it&#xD;
      ends, motivational strategies based on the self-determination theory will be used. Specific&#xD;
      strategies will be developed for this group, based on previous works and educational guides&#xD;
      for colorectal cancer patients. The instructor in charge of directing the program will be&#xD;
      trained in several sessions to use motivational strategies based on this theory. Once the&#xD;
      program is finished, an educational guide of motivational strategies for the promotion of PA&#xD;
      in patients with colorectal cancer will be developed and published from the perspective of&#xD;
      self-determination theory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Rockport 1-mile walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>In the middle of the intervention (at 3 months)</time_frame>
    <description>Rockport 1-mile walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Rockport 1-mile walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Rockport 1-mile walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>In the middle of the intervention (at 3 months)</time_frame>
    <description>Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)</measure>
    <time_frame>In the middle of the intervention (at 3 months)</time_frame>
    <description>Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation in exercise context</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation in exercise context</measure>
    <time_frame>In the middle of the intervention (at 3 months)</time_frame>
    <description>Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation in exercise context</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation in exercise context</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Pre intervention</time_frame>
    <description>waist and hip circumference/ waist and hip index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>In the middle of the intervention (at 3 months)</time_frame>
    <description>waist and hip circumference/ waist and hip index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>waist and hip circumference/ waist and hip index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>waist and hip circumference/ waist and hip index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy support questionnaire</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy support questionnaire</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy support questionnaire</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy support questionnaire</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)</measure>
    <time_frame>Pre intervention</time_frame>
    <description>In general life context (from 1 to 5 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>In general life context (from 1 to 5 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>In general life context (from 1 to 5 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>In general life context (from 1 to 5 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The scale of Basic Psychological Needs in Exercise (BPNES) will be used</measure>
    <time_frame>Pre intervention</time_frame>
    <description>In exercise context (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The scale of Basic Psychological Needs in Exercise (BPNES) will be used</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The scale of Basic Psychological Needs in Exercise (BPNES) will be used</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The scale of Basic Psychological Needs in Exercise (BPNES) will be used</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived barriers to physical activity participation questionnaire</measure>
    <time_frame>Pre intervention</time_frame>
    <description>On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived barriers to physical activity participation questionnaire</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived barriers to physical activity participation questionnaire</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived barriers to physical activity participation questionnaire</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope State Questionnaire</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Scale of hope state to face the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope State Questionnaire</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>Scale of hope state to face the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope State Questionnaire</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Scale of hope state to face the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope State Questionnaire</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Scale of hope state to face the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition questionnaire</measure>
    <time_frame>Pre intervention</time_frame>
    <description>International Fitness Scale (IFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition questionnaire</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>International Fitness Scale (IFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition questionnaire</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>International Fitness Scale (IFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition questionnaire</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>International Fitness Scale (IFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of the chemotherapy</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Fatigue questionnaire FACIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of the chemotherapy</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>Fatigue questionnaire FACIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of the chemotherapy</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Fatigue questionnaire FACIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of the chemotherapy</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Fatigue questionnaire FACIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (subjective)</measure>
    <time_frame>Pre intervention</time_frame>
    <description>International physical activity questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (subjective)</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>International physical activity questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (subjective)</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>International physical activity questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (subjective)</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>International physical activity questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (objective)</measure>
    <time_frame>Pre intervention</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (objective)</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (objective)</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels (objective)</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>Pre intervention</time_frame>
    <description>The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>In the middle of intervention (at 3 months)</time_frame>
    <description>The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>At 6 months after the start of the intervention</time_frame>
    <description>The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>One year after the start of the intervention</time_frame>
    <description>The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Quality of Life</condition>
  <condition>Physical Exercise</condition>
  <condition>Motivation</condition>
  <condition>Side Effect</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not training group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not do any intervention, they only will be perform the pre and post-tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life</description>
    <arm_group_label>Training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Being more than 18 years&#xD;
&#xD;
          -  Colorectal cancer stage II and III&#xD;
&#xD;
          -  Be receiving adjuvant chemotherapy treatment after surgery&#xD;
&#xD;
          -  Ecog &gt; 1&#xD;
&#xD;
          -  No medical contraindications&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Have a disability&#xD;
&#xD;
          -  Colorectal cancer stage IV&#xD;
&#xD;
          -  Presence of metastasis&#xD;
&#xD;
          -  Ecog &lt; 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David González-Cutre Coll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miguel Hernández University of Elche</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David González-Cutre Coll, PhD</last_name>
    <phone>+34657697920</phone>
    <email>dgonzalez-cutre@umh.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ana Ruíz Casado, MD, PhD</last_name>
    <phone>+34607890187</phone>
    <email>anaruizcasado@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidad Miguel Hernández</name>
      <address>
        <city>Elche</city>
        <state>Elche/Alicante</state>
        <zip>03202</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David González-Cutre, PhD</last_name>
      <phone>+34657697920</phone>
      <email>dgonzález-cutre@umh.es</email>
    </contact>
    <investigator>
      <last_name>María Romero-Elías, MsC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <state>Majadahonda/Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Ruiz-Casado, Oncologist</last_name>
      <phone>+34607890187</phone>
      <email>anaruizcasado@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.</citation>
    <PMID>8433390</PMID>
  </reference>
  <reference>
    <citation>Alvero Cruz, J. R., Armesilla, M. D. C., Herrero-de-Lucas, A., Riaza, L. M., Pascual, C. M., Manzañido, J. P., … Belando, J. E. S. (2010). Body composition assessment in sports medicine. Statement of Spanish group of kinanthropometry of Spanish federation of sports medicine. Version 2010. Archivos de Medicina del Deporte, 27, 330-344.</citation>
  </reference>
  <reference>
    <citation>Arraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.</citation>
    <PMID>21239355</PMID>
  </reference>
  <reference>
    <citation>Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999b). Understanding exercise motivation in colorectal cancer patients: A prospective study using the theory of planned behavior. Rehabilitation Psychology, 44, 68-84.</citation>
  </reference>
  <reference>
    <citation>Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999a). Physical exercise and quality of life in postsurgical colorectal cancer patients. Psychology, Health, &amp; Medicine, 4, 181-187.</citation>
  </reference>
  <reference>
    <citation>Courneya KS, Friedenreich CM, Quinney HA, Fields AL, Jones LW, Fairey AS. Predictors of adherence and contamination in a randomized trial of exercise in colorectal cancer survivors. Psychooncology. 2004 Dec;13(12):857-66. doi: 10.1002/pon.802.</citation>
    <PMID>15386794</PMID>
  </reference>
  <reference>
    <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
    <PMID>12900694</PMID>
  </reference>
  <reference>
    <citation>Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct;52(20):1311. doi: 10.1136/bjsports-2017-098285. Epub 2018 Mar 16.</citation>
    <PMID>29549149</PMID>
  </reference>
  <reference>
    <citation>Garcia DO, Thomson CA. Physical activity and cancer survivorship. Nutr Clin Pract. 2014 Dec;29(6):768-79. doi: 10.1177/0884533614551969. Epub 2014 Oct 21.</citation>
    <PMID>25335787</PMID>
  </reference>
  <reference>
    <citation>HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.</citation>
    <PMID>13638508</PMID>
  </reference>
  <reference>
    <citation>HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.</citation>
    <PMID>14399272</PMID>
  </reference>
  <reference>
    <citation>Lobo A, Chamorro L, Luque A, Dal-Re R, Badia X, Baro E; Grupo de Validacion en Espanol de Escalas Psicometricas (GVEEP). [Validation of the Spanish versions of the Montgomery-Asberg depression and Hamilton anxiety rating scales]. Med Clin (Barc). 2002 Apr 13;118(13):493-9. doi: 10.1016/s0025-7753(02)72429-9. Spanish.</citation>
    <PMID>11975886</PMID>
  </reference>
  <reference>
    <citation>Ng JY, Ntoumanis N, Thogersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, Williams GC. Self-Determination Theory Applied to Health Contexts: A Meta-Analysis. Perspect Psychol Sci. 2012 Jul;7(4):325-40. doi: 10.1177/1745691612447309.</citation>
    <PMID>26168470</PMID>
  </reference>
  <reference>
    <citation>Peddle CJ, Plotnikoff RC, Wild TC, Au HJ, Courneya KS. Medical, demographic, and psychosocial correlates of exercise in colorectal cancer survivors: an application of self-determination theory. Support Care Cancer. 2008 Jan;16(1):9-17. doi: 10.1007/s00520-007-0272-5. Epub 2007 Jun 15.</citation>
    <PMID>17569994</PMID>
  </reference>
  <reference>
    <citation>Rantanen T, Guralnik JM, Foley D, Masaki K, Leveille S, Curb JD, White L. Midlife hand grip strength as a predictor of old age disability. JAMA. 1999 Feb 10;281(6):558-60. doi: 10.1001/jama.281.6.558.</citation>
    <PMID>10022113</PMID>
  </reference>
  <reference>
    <citation>Roman, B., Serra-Majem, L., Hagstromer, M., Ramon, J., Ribas, L., y Sjostrom, M. (2006). International Physical Activity Questionnaire: Reliability and validity in Spain. Medicine and Science in Sports and Exercise, 38, S563. doi:10.1249/00005768-200605001-03214</citation>
  </reference>
  <reference>
    <citation>Romero-Elías, M., González-Cutre, D., Beltrán-Carrillo, V. J., y Cervelló, E. (2017). Factors that promote or hinder physical activity participation in patients with colorectal cancer: A systematic review. Psychology, Society, &amp; Education, 9, 201-226.</citation>
  </reference>
  <reference>
    <citation>Ruiz-Casado A, Verdugo AS, Solano MJ, Aldazabal IP, Fiuza-Luces C, Alejo LB, del Hierro JR, Palomo I, Aguado-Arroyo O, Garatachea N, Cebolla H, Lucia A. Objectively assessed physical activity levels in Spanish cancer survivors. Oncol Nurs Forum. 2014 Jan 1;41(1):E12-20. doi: 10.1188/14.ONF.E12-E20.</citation>
    <PMID>24368248</PMID>
  </reference>
  <reference>
    <citation>Ryan, R. M., y Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. New York: Guilford Press.</citation>
  </reference>
  <reference>
    <citation>Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.</citation>
    <PMID>20559064</PMID>
  </reference>
  <reference>
    <citation>Spence RR, Heesch KC, Brown WJ. Colorectal cancer survivors' exercise experiences and preferences: qualitative findings from an exercise rehabilitation programme immediately after chemotherapy. Eur J Cancer Care (Engl). 2011 Mar;20(2):257-66. doi: 10.1111/j.1365-2354.2010.01214.x.</citation>
    <PMID>20649808</PMID>
  </reference>
  <reference>
    <citation>Vlachopoulos, S. P., y Michailidou, S. (2006). Development and initial validation of a measure of autonomy, competence, and relatedness in exercise: The Basic Psychological Needs in Exercise Scale. Measurement in Physical Education and Exercise Science, 10, 179-201.</citation>
  </reference>
  <reference>
    <citation>Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.</citation>
    <PMID>19765978</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Miguel Hernandez de Elche</investigator_affiliation>
    <investigator_full_name>David González-Cutre Coll</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>Exercise</keyword>
  <keyword>Motivation</keyword>
  <keyword>Cancer</keyword>
  <keyword>Well-being</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506840
org study id: DPS.DGC.01.19
nct id: NCT04506840
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The intervention will be a physical exercise program for colorectal cancer patients during
      the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the
      treatment and improving patients' quality of life. In addition, the investigators try to
      improve endurance and resistance training level, in order to achieve greater physical
      functionality, survival and general well-being. For this, the investigators will carry out an
      exercise program based mainly on muscular strength and cardiorespiratory condition. It will
      last 6 months, with a frequency of 3 days per week, including sessions of 60 minutes.
      Sessions will consist of three parts: warm-up, main part (endurance and resistance training),
      and cool down. An individualized and supervised progression of training will take place. The
      intensity levels will always be adjusted to the initial levels of the participants, always
      considering their preferences and comfort.

      Participants' preferences and exercise history will be considered through an initial
      interview. Motivational strategies based on self-determination theory will be applied, since
      it is one of the most used theories in the field of physical exercise. This theory proposes
      that all people need to feel competent, autonomous and socially related. If these three needs
      are satisfied, participants will develop more positive (autonomous) forms of motivation,
      which are related to better consequences such as vitality, enjoyment, quality of life and
      adherence to physical activity. In addition, motivational strategies will be applied for
      families and healthcare professionals.

      Before starting the program and at the end of it, each eligible patient will be evaluated
      through:

        -  Physical activity: strength test of lower and upper limbs, agility test, stress test for
           cardiorespiratory fitness, physical activity levels, physical condition and body
           composition.

        -  Psychological factors: autonomy support, basic psychological need satisfaction,
           motivation, quality of life, perceived barriers, depression, anxiety, hope, quality of
           life.

        -  Clinical parameters: survival rate, side effects, biological factors, treatment delays
           and planned treatment completion.
Objectives and justification of the project In Spain, cancer is the second cause of death
      after cardiovascular diseases. However, if it is divided by sex, cancer is the leading cause
      of death for men and the second cause for women. In recent years there has been an increase
      in new cases of cancer due to population growth and aging, since 2/3 of cancer patients are
      older than 65 years. In addition to the impact of this disease on people's quality of life, a
      high economic cost has been estimated for the health system. For example, the total cost of
      cancer in 2015 in Spain was 7,168 million euros. This situation represents an important
      public health problem and therefore implies that research on the factors that can prevent or
      alleviate this disease should be considered as a priority.

      In this regard, there is increasing scientific evidence of the physical and psychosocial
      benefits of exercise both during and after the treatment of this disease. Nevertheless, only
      30-40% of cancer survivors perform the necessary physical activity (PA) recommended by the
      main medical institutions. In fact, a significant number of patients are obese (33%) and have
      a low cardiorespiratory condition (45%). Despite this, PA continues to decrease after
      diagnosis and only 5-10% of patients are physically active during treatment and 20-30% after
      treatment. Therefore, the development of intervention programs aimed at promoting PA should
      be a fundamental objective in the fight against cancer and its physical and psychosocial
      consequences. In this line, our general objective will be to develop a motivation PA program
      for colorectal cancer patients. Specifically, and considering the gaps existing in the
      current literature, our general objective is subdivided into the following specific
      objectives:

        -  To evaluate the physical, psychosocial and behavioural effects, in the short and medium
           term, of a physical exercise program in which motivational strategies based on
           self-determination theory are applied.

        -  To explore qualitatively the benefits of the physical exercise program, as well as the
           troubles encountered in its implementation.

        -  To develop an educational guide and an intervention protocol to encourage motivation and
           adherence to PA of colorectal cancer patients.

      Methodology This study will require a sample size of 34 patients. This calculation was made
      through the G*power software, by means of an analysis of variance (ANOVA), adjusting the
      values to p <.05, with a statistical power of 80% and an effect size of 0.5. The patients
      will be recently diagnosed with colorectal cancer in phases II-III by the oncology service of
      the Hospital Universitario Puerta de Hierro de Majadahonda. Inclusion criteria include to be
      between 18 and 75 years old, to be undergoing chemotherapy treatment, and to not have any
      type of associated pathology that prevents them from performing PA. A intervention with an
      experimental group and a control group will be conducted, where 17 patients will be assigned
      to a control group, and 17 patients will perform a supervised motivational exercise program.

      Measures Cardiorespiratory fitness. Stress tests adapted to the characteristics of the
      patients will be performed, both in the type of ergometer and in the protocol. We will use
      electrocardiographic recording and gas exchange analysis. Aerobic and anaerobic exercise
      thresholds will be established.

      Quality of life. The validated Spanish version of the EORTC-QLQ-CR30 will be used for
      patients with colorectal cancer.

      Body composition. Anthropometries will be carried out to estimate body composition
      parameters.

      Biological parameters. The usual analytics carried out in the hospital during the treatment
      will be used to check the patient's health status and the side effects of the chemotherapy
      treatment.

      Anxiety. The validated version in Spanish of the Hamilton Anxiety Scale will be used.

      Depression. The Spanish version of the Hamilton Depression Scale will be used. Autonomy
      support. The Spanish version of the Perceived Autonomy Support for Exercise Settings will be
      used.

      Perceived barriers to do PA. This scale will be translated and validated to the Spanish
      context.

      Basic psychological needs in exercise. We will use the Basic Psychological Needs in Exercise
      Scale.

      Basic psychological needs in life. The Spanish version of the Basic Psychological Need
      Satisfaction and Frustration Scale will be used.

      Types of motivation. To measure motivation towards PA, the Behavioural Regulation in Exercise
      Questionnaire will be for PA levels. The Spanish version of the IPAQ questionnaire will be
      used. On the other hand, PA will be measured in a direct and objective way through portable
      GT3X accelerometers.

      Design, procedure and data analysis The intervention program will be carried out at the
      Hospital Universitario Puerta de Hierro of Majadahonda. The program will last 6 months, with
      three weekly one-hour sessions, and will comply with the recommendations established by the
      American Cancer Society and the American College of Sports Medicine. The safety precautions
      and contraindications identified by these institutions for colorectal cancer patients will be
      especially considered. The program will include aerobic sessions at moderate and vigorous
      intensities, as well as strength work. Patients will be monitored to model exercise loads
      individually.

      The measurements will be made just before starting the PA program (T1) in the case of the
      experimental group, at an initial time of the equivalent treatment in the case of the control
      group. The same measures will be carried out 6 months later (T2). For PA levels, instead of
      measuring them just after the end of the program, we will wait another month so that patients
      have been able to recover their usual PA levels after the shock that can mean for them to
      face the end of our program. In the control group, PA levels will also be evaluated one month
      after T2. To test the effects of the program, all measurements will be performed 6 months
      after T2 in both groups (T3).

      Additionally, qualitative methodology will be used, so that the 17 patients of the
      experimental group will be interviewed to know the factors related to their adherence to the
      PA program and the benefits perceived by them with their participation. Qualitative data
      collection will be reinforced with field notes compiled in research diaries by observers who
      will be present during the development of the program. Relatives and health professionals
      will also be interviewed to learn their perspective regarding the benefits of the program and
      adherence to it in these patients.

      In order to promote adherence to the program and to educate in autonomous PA habits when it
      ends, motivational strategies based on the self-determination theory will be used. Specific
      strategies will be developed for this group, based on previous works and educational guides
      for colorectal cancer patients. The instructor in charge of directing the program will be
      trained in several sessions to use motivational strategies based on this theory. Once the
      program is finished, an educational guide of motivational strategies for the promotion of PA
      in patients with colorectal cancer will be developed and published from the perspective of
      self-determination theory.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cardiorespiratory fitness
time frame: Pre intervention
description: Rockport 1-mile walking test
measure: Cardiorespiratory fitness
time frame: In the middle of the intervention (at 3 months)
description: Rockport 1-mile walking test
measure: Cardiorespiratory fitness
time frame: At 6 months after the start of the intervention
description: Rockport 1-mile walking test
measure: Cardiorespiratory fitness
time frame: One year after the start of the intervention
description: Rockport 1-mile walking test
measure: Strength
time frame: Pre intervention
description: Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure: Strength
time frame: In the middle of the intervention (at 3 months)
description: Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure: Strength
time frame: At 6 months after the start of the intervention
description: Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure: Strength
time frame: One year after the start of the intervention
description: Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure: Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
time frame: Pre intervention
description: Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure: Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
time frame: In the middle of the intervention (at 3 months)
description: Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure: Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
time frame: At 6 months after the start of the intervention
description: Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure: Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
time frame: One year after the start of the intervention
description: Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure: Motivation in exercise context
time frame: Pre intervention
description: Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure: Motivation in exercise context
time frame: In the middle of the intervention (at 3 months)
description: Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure: Motivation in exercise context
time frame: At 6 months after the start of the intervention
description: Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure: Motivation in exercise context
time frame: One year after the start of the intervention
description: Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure: Body composition
time frame: Pre intervention
description: waist and hip circumference/ waist and hip index
measure: Body composition
time frame: In the middle of the intervention (at 3 months)
description: waist and hip circumference/ waist and hip index
measure: Body composition
time frame: At 6 months after the start of the intervention
description: waist and hip circumference/ waist and hip index
measure: Body composition
time frame: One year after the start of the intervention
description: waist and hip circumference/ waist and hip index
measure: Autonomy support questionnaire
time frame: Pre intervention
description: Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure: Autonomy support questionnaire
time frame: In the middle of intervention (at 3 months)
description: Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure: Autonomy support questionnaire
time frame: At 6 months after the start of the intervention
description: Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure: Autonomy support questionnaire
time frame: One year after the start of the intervention
description: Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
time frame: Pre intervention
description: In general life context (from 1 to 5 points)
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
time frame: In the middle of intervention (at 3 months)
description: In general life context (from 1 to 5 points)
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
time frame: At 6 months after the start of the intervention
description: In general life context (from 1 to 5 points)
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
time frame: One year after the start of the intervention
description: In general life context (from 1 to 5 points)
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
time frame: Pre intervention
description: In exercise context (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
time frame: In the middle of intervention (at 3 months)
description: (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
time frame: At 6 months after the start of the intervention
description: (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
time frame: One year after the start of the intervention
description: (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure: Perceived barriers to physical activity participation questionnaire
time frame: Pre intervention
description: On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure: Perceived barriers to physical activity participation questionnaire
time frame: In the middle of intervention (at 3 months)
description: On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure: Perceived barriers to physical activity participation questionnaire
time frame: At 6 months after the start of the intervention
description: On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure: Perceived barriers to physical activity participation questionnaire
time frame: One year after the start of the intervention
description: On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure: Hope State Questionnaire
time frame: Pre intervention
description: Scale of hope state to face the disease
measure: Hope State Questionnaire
time frame: In the middle of intervention (at 3 months)
description: Scale of hope state to face the disease
measure: Hope State Questionnaire
time frame: At 6 months after the start of the intervention
description: Scale of hope state to face the disease
measure: Hope State Questionnaire
time frame: One year after the start of the intervention
description: Scale of hope state to face the disease
measure: Physical condition questionnaire
time frame: Pre intervention
description: International Fitness Scale (IFI)
measure: Physical condition questionnaire
time frame: In the middle of intervention (at 3 months)
description: International Fitness Scale (IFI)
measure: Physical condition questionnaire
time frame: At 6 months after the start of the intervention
description: International Fitness Scale (IFI)
measure: Physical condition questionnaire
time frame: One year after the start of the intervention
description: International Fitness Scale (IFI)
measure: Side effects of the chemotherapy
time frame: Pre intervention
description: Fatigue questionnaire FACIT
measure: Side effects of the chemotherapy
time frame: In the middle of intervention (at 3 months)
description: Fatigue questionnaire FACIT
measure: Side effects of the chemotherapy
time frame: At 6 months after the start of the intervention
description: Fatigue questionnaire FACIT
measure: Side effects of the chemotherapy
time frame: One year after the start of the intervention
description: Fatigue questionnaire FACIT
measure: Physical activity levels (subjective)
time frame: Pre intervention
description: International physical activity questionnaire (IPAQ)
measure: Physical activity levels (subjective)
time frame: In the middle of intervention (at 3 months)
description: International physical activity questionnaire (IPAQ)
measure: Physical activity levels (subjective)
time frame: At 6 months after the start of the intervention
description: International physical activity questionnaire (IPAQ)
measure: Physical activity levels (subjective)
time frame: One year after the start of the intervention
description: International physical activity questionnaire (IPAQ)
measure: Physical activity levels (objective)
time frame: Pre intervention
description: Accelerometer
measure: Physical activity levels (objective)
time frame: In the middle of intervention (at 3 months)
description: Accelerometer
measure: Physical activity levels (objective)
time frame: At 6 months after the start of the intervention
description: Accelerometer
measure: Physical activity levels (objective)
time frame: One year after the start of the intervention
description: Accelerometer
measure: Depression and anxiety
time frame: Pre intervention
description: The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure: Depression and anxiety
time frame: In the middle of intervention (at 3 months)
description: The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure: Depression and anxiety
time frame: At 6 months after the start of the intervention
description: The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure: Depression and anxiety
time frame: One year after the start of the intervention
description: The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
arm group label: Training group
arm group type: Experimental
description: Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment
arm group label: Not training group
arm group type: No Intervention
description: Participants will not do any intervention, they only will be perform the pre and post-tests.
intervention type: Other
intervention name: Physical activity
description: Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life
arm group label: Training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David González-Cutre Coll, PhD
role: Principal Investigator
affiliation: Miguel Hernández University of Elche
last name: David González-Cutre Coll, PhD
phone: +34657697920
email: dgonzalez-cutre@umh.es
last name: Ana Ruíz Casado, MD, PhD
phone: +34607890187
email: anaruizcasado@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Spain
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PMID: 8433390
citation: Alvero Cruz, J. R., Armesilla, M. D. C., Herrero-de-Lucas, A., Riaza, L. M., Pascual, C. M., Manzañido, J. P., … Belando, J. E. S. (2010). Body composition assessment in sports medicine. Statement of Spanish group of kinanthropometry of Spanish federation of sports medicine. Version 2010. Archivos de Medicina del Deporte, 27, 330-344.
citation: Arraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.
PMID: 21239355
citation: Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999b). Understanding exercise motivation in colorectal cancer patients: A prospective study using the theory of planned behavior. Rehabilitation Psychology, 44, 68-84.
citation: Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999a). Physical exercise and quality of life in postsurgical colorectal cancer patients. Psychology, Health, & Medicine, 4, 181-187.
citation: Courneya KS, Friedenreich CM, Quinney HA, Fields AL, Jones LW, Fairey AS. Predictors of adherence and contamination in a randomized trial of exercise in colorectal cancer survivors. Psychooncology. 2004 Dec;13(12):857-66. doi: 10.1002/pon.802.
PMID: 15386794
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PMID: 12900694
citation: Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct;52(20):1311. doi: 10.1136/bjsports-2017-098285. Epub 2018 Mar 16.
PMID: 29549149
citation: Garcia DO, Thomson CA. Physical activity and cancer survivorship. Nutr Clin Pract. 2014 Dec;29(6):768-79. doi: 10.1177/0884533614551969. Epub 2014 Oct 21.
PMID: 25335787
citation: HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
PMID: 13638508
citation: HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PMID: 14399272
citation: Lobo A, Chamorro L, Luque A, Dal-Re R, Badia X, Baro E; Grupo de Validacion en Espanol de Escalas Psicometricas (GVEEP). [Validation of the Spanish versions of the Montgomery-Asberg depression and Hamilton anxiety rating scales]. Med Clin (Barc). 2002 Apr 13;118(13):493-9. doi: 10.1016/s0025-7753(02)72429-9. Spanish.
PMID: 11975886
citation: Ng JY, Ntoumanis N, Thogersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, Williams GC. Self-Determination Theory Applied to Health Contexts: A Meta-Analysis. Perspect Psychol Sci. 2012 Jul;7(4):325-40. doi: 10.1177/1745691612447309.
PMID: 26168470
citation: Peddle CJ, Plotnikoff RC, Wild TC, Au HJ, Courneya KS. Medical, demographic, and psychosocial correlates of exercise in colorectal cancer survivors: an application of self-determination theory. Support Care Cancer. 2008 Jan;16(1):9-17. doi: 10.1007/s00520-007-0272-5. Epub 2007 Jun 15.
PMID: 17569994
citation: Rantanen T, Guralnik JM, Foley D, Masaki K, Leveille S, Curb JD, White L. Midlife hand grip strength as a predictor of old age disability. JAMA. 1999 Feb 10;281(6):558-60. doi: 10.1001/jama.281.6.558.
PMID: 10022113
citation: Roman, B., Serra-Majem, L., Hagstromer, M., Ramon, J., Ribas, L., y Sjostrom, M. (2006). International Physical Activity Questionnaire: Reliability and validity in Spain. Medicine and Science in Sports and Exercise, 38, S563. doi:10.1249/00005768-200605001-03214
citation: Romero-Elías, M., González-Cutre, D., Beltrán-Carrillo, V. J., y Cervelló, E. (2017). Factors that promote or hinder physical activity participation in patients with colorectal cancer: A systematic review. Psychology, Society, & Education, 9, 201-226.
citation: Ruiz-Casado A, Verdugo AS, Solano MJ, Aldazabal IP, Fiuza-Luces C, Alejo LB, del Hierro JR, Palomo I, Aguado-Arroyo O, Garatachea N, Cebolla H, Lucia A. Objectively assessed physical activity levels in Spanish cancer survivors. Oncol Nurs Forum. 2014 Jan 1;41(1):E12-20. doi: 10.1188/14.ONF.E12-E20.
PMID: 24368248
citation: Ryan, R. M., y Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. New York: Guilford Press.
citation: Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.
PMID: 20559064
citation: Spence RR, Heesch KC, Brown WJ. Colorectal cancer survivors' exercise experiences and preferences: qualitative findings from an exercise rehabilitation programme immediately after chemotherapy. Eur J Cancer Care (Engl). 2011 Mar;20(2):257-66. doi: 10.1111/j.1365-2354.2010.01214.x.
PMID: 20649808
citation: Vlachopoulos, S. P., y Michailidou, S. (2006). Development and initial validation of a measure of autonomy, competence, and relatedness in exercise: The Basic Psychological Needs in Exercise Scale. Measurement in Physical Education and Exercise Science, 10, 179-201.
citation: Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.
PMID: 19765978
responsible party type: Principal Investigator
investigator affiliation: Universidad Miguel Hernandez de Elche
investigator full name: David González-Cutre Coll
investigator title: Senior Lecturer
mesh term: Colorectal Neoplasms
sharing ipd: No