<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/NCT03819595</url>
  </required_header>
  <id_info>
    <org_study_id>PI 18/00929</org_study_id>
    <nct_id>NCT03819595</nct_id>
  </id_info>
  <brief_title>BIZI ORAIN: Exercise for All People With Cancer</brief_title>
  <official_title>&quot;BIZI ORAIN&quot;: Exercise for All People With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Physical exercise should be an essential component of the therapeutic plan for&#xD;
      every person diagnosed with cancer. However, most of these patients are inactive and only a&#xD;
      few of them receive prescription and follow-up for safe and effective exercise plans.&#xD;
&#xD;
      Objective: in a first experimental phase, we will evaluate actual implementation (reach and&#xD;
      adherence) and clinical effectiveness (physical fitness, quality of life and symptoms) of the&#xD;
      BIZI ORAIN (BO) exercise program, for all patients diagnosed with cancer, compared to&#xD;
      standardized physical activity counseling. In a second, observational phase, we will evaluate&#xD;
      the association between levels of physical activity actually performed by all the&#xD;
      participants and their 12 months evolution, in terms of physical fitness, quality of life,&#xD;
      symptomatology and survival.&#xD;
&#xD;
      Design: Hybrid study, with a first experimental phase in which patients diagnosed with cancer&#xD;
      will be randomly assigned to two parallel groups, one that immediately performs the BO&#xD;
      program for 12 weeks and the other one that performs the same programme three months later&#xD;
      (delayed treatment). In the second phase, observational, the entire cohort of participants&#xD;
      will be followed-up for one year. Population: Any person diagnosed with cancer in the&#xD;
      previous two years (minimum sample size = 1013) free of bone metastases, hematological or&#xD;
      other exercise contraindications.&#xD;
&#xD;
      BIZI ORAIN program: based on the &quot;Life Now&quot; program of the Australian Cancer Council, BO is a&#xD;
      12-week small-group exercise program supervised by specially trained instructors combining&#xD;
      moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).&#xD;
&#xD;
      Outcome measurements: the main outcome variable will be the change in functional capacity at&#xD;
      three months (400 meters walk test). Secondary variables include mortality, quality of life&#xD;
      (general SF-36 and cancer specific quality of life -European Organization for Research and&#xD;
      Treatment of Cancer QLQ-C-30-), symptoms (Cancer-related fatigue - Functional Assessment of&#xD;
      Chronic Illness Therapy-Fatigue (FACIT-Fatigue), exposure to physical activity level&#xD;
      objectively registered with Actigraph wGT3X-BT accelerometer, chronic inflammation&#xD;
      (C-reactive protein, adiponectin, and pro-inflammatory cytokines Il-1, Il-6 , and TNF-), body&#xD;
      composition and bone health (dual-energy X-ray absorptiometry), measured at 0, 3, 6, and 12&#xD;
      months.&#xD;
&#xD;
      Analyses: changes observed in the outcome variables at three months will be compared between&#xD;
      patients assigned to BO and to the reference group (delayed treatment) using analysis of the&#xD;
      covariance, adjusted for baseline levels. To analyze the association between over time change&#xD;
      in physical activity and the outcome variables mixed effects longitudinal models will be used&#xD;
      for repeated measures throughout the 12 months of follow-up. Cox proportional hazards models&#xD;
      will be used for the survival analysis. Qualitative analyses will combine a deductive&#xD;
      approach with an inductive one based on Grounded Theory. In the deductive approach, the&#xD;
      researchers will identify several thematic categories related to the Consolidated Framework&#xD;
      for Implementation Research. Conclusions: BO is the first experience in Spain of a&#xD;
      population-based exercise program that will guarantee, through a scientific evaluation, both&#xD;
      clinical and implementation results. This will drastically advance the treatment of people&#xD;
      suffering from cancer helping them to reverse the effects of their disease, the adverse&#xD;
      effects of the therapies and to improve anti-cancer treatment efficacy, their quality of life&#xD;
      and survival&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Capacity (400 meters walk test)</measure>
    <time_frame>One year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>The 400 meters walk Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0, 3,6 and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life (general SF-36)</measure>
    <time_frame>1 year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population. Measured at 0, 3, 6 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life (cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30)</measure>
    <time_frame>1 year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity).Measured at 0, 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)</measure>
    <time_frame>1 year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from &quot;4&quot;. After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL. Measured at 0, 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity level</measure>
    <time_frame>1 year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0, 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of Lipids</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>Lipids:cholesterol (mg/dl), tryglicerides (mg/dl), HDL (mg/dl), LDL(mg/dl). Measured at baseline, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of C reactive protein</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>C reactive protein (mg/l). Measured at 0, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of glucose</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>glycemia (mg/dl). Measured at 0, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of Insulin</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>Insulin (microU/ml). Measured at 0, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of adiponectin</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of TNF</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>Exercise specific parameters: TNF in Cancer patients (pg/ml) .Measured at baseline, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of Interleukins II-1 and II-6</measure>
    <time_frame>3 months. Measures at 0,3 months.</time_frame>
    <description>Exercise specific parameters: Interleukins II-1 and II-6 (pg/ml). Measured at baseline, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body composition (fat and muscular weight). (BMI)</measure>
    <time_frame>1 year follow up. Measures at 0,3,6 and 12 months</time_frame>
    <description>Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m^2). Measured at baseline, and 3, 6, 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Functional Capacity</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Supervised arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supervised exercise. The intervention will be a free 12-week, small-group (~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supervised exercise.The intervention will be a Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation.&#xD;
After 3 months, it become supervised arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised exercise</intervention_name>
    <description>a free 12-week, small-group (~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Supervised arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized Program PVS</intervention_name>
    <description>a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool &quot;Promote Healthy Living&quot; integrated into the electronic medical record.</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People diagnosed with cancer within the previous 2 years, under treatment or finished&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neutropenia&#xD;
&#xD;
          -  severe anemia&#xD;
&#xD;
          -  bone metastases&#xD;
&#xD;
          -  any musculoskeletal, cardiovascular or neurological disorder that could place the&#xD;
             participant at risk of injury or illness resulting from the exercise program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nere Mendizabal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Basque Health Service</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary care research unit of Bizkaia</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Nere Mendizabal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03819595
org study id: PI 18/00929
nct id: NCT03819595
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Physical exercise should be an essential component of the therapeutic plan for
      every person diagnosed with cancer. However, most of these patients are inactive and only a
      few of them receive prescription and follow-up for safe and effective exercise plans.

      Objective: in a first experimental phase, we will evaluate actual implementation (reach and
      adherence) and clinical effectiveness (physical fitness, quality of life and symptoms) of the
      BIZI ORAIN (BO) exercise program, for all patients diagnosed with cancer, compared to
      standardized physical activity counseling. In a second, observational phase, we will evaluate
      the association between levels of physical activity actually performed by all the
      participants and their 12 months evolution, in terms of physical fitness, quality of life,
      symptomatology and survival.

      Design: Hybrid study, with a first experimental phase in which patients diagnosed with cancer
      will be randomly assigned to two parallel groups, one that immediately performs the BO
      program for 12 weeks and the other one that performs the same programme three months later
      (delayed treatment). In the second phase, observational, the entire cohort of participants
      will be followed-up for one year. Population: Any person diagnosed with cancer in the
      previous two years (minimum sample size = 1013) free of bone metastases, hematological or
      other exercise contraindications.

      BIZI ORAIN program: based on the "Life Now" program of the Australian Cancer Council, BO is a
      12-week small-group exercise program supervised by specially trained instructors combining
      moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).

      Outcome measurements: the main outcome variable will be the change in functional capacity at
      three months (400 meters walk test). Secondary variables include mortality, quality of life
      (general SF-36 and cancer specific quality of life -European Organization for Research and
      Treatment of Cancer QLQ-C-30-), symptoms (Cancer-related fatigue - Functional Assessment of
      Chronic Illness Therapy-Fatigue (FACIT-Fatigue), exposure to physical activity level
      objectively registered with Actigraph wGT3X-BT accelerometer, chronic inflammation
      (C-reactive protein, adiponectin, and pro-inflammatory cytokines Il-1, Il-6 , and TNF-), body
      composition and bone health (dual-energy X-ray absorptiometry), measured at 0, 3, 6, and 12
      months.

      Analyses: changes observed in the outcome variables at three months will be compared between
      patients assigned to BO and to the reference group (delayed treatment) using analysis of the
      covariance, adjusted for baseline levels. To analyze the association between over time change
      in physical activity and the outcome variables mixed effects longitudinal models will be used
      for repeated measures throughout the 12 months of follow-up. Cox proportional hazards models
      will be used for the survival analysis. Qualitative analyses will combine a deductive
      approach with an inductive one based on Grounded Theory. In the deductive approach, the
      researchers will identify several thematic categories related to the Consolidated Framework
      for Implementation Research. Conclusions: BO is the first experience in Spain of a
      population-based exercise program that will guarantee, through a scientific evaluation, both
      clinical and implementation results. This will drastically advance the treatment of people
      suffering from cancer helping them to reverse the effects of their disease, the adverse
      effects of the therapies and to improve anti-cancer treatment efficacy, their quality of life
      and survival
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Functional Capacity (400 meters walk test)
time frame: One year follow up. Measures at 0,3,6 and 12 months
description: The 400 meters walk Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0, 3,6 and 12 months.
measure: Change in Quality of life (general SF-36)
time frame: 1 year follow up. Measures at 0,3,6 and 12 months
description: The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population. Measured at 0, 3, 6 and 12 months.
measure: Change in Quality of life (cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30)
time frame: 1 year follow up. Measures at 0,3,6 and 12 months
description: Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity).Measured at 0, 3, 6 and 12 months
measure: symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
time frame: 1 year follow up. Measures at 0,3,6 and 12 months
description: a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from "4". After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL. Measured at 0, 3, 6 and 12 months
measure: physical activity level
time frame: 1 year follow up. Measures at 0,3,6 and 12 months
description: objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0, 3, 6 and 12 months
measure: concentration of Lipids
time frame: 3 months. Measures at 0,3 months.
description: Lipids:cholesterol (mg/dl), tryglicerides (mg/dl), HDL (mg/dl), LDL(mg/dl). Measured at baseline, and 3 months
measure: concentration of C reactive protein
time frame: 3 months. Measures at 0,3 months.
description: C reactive protein (mg/l). Measured at 0, and 3 months
measure: concentration of glucose
time frame: 3 months. Measures at 0,3 months.
description: glycemia (mg/dl). Measured at 0, and 3 months
measure: concentration of Insulin
time frame: 3 months. Measures at 0,3 months.
description: Insulin (microU/ml). Measured at 0, and 3 months
measure: concentration of adiponectin
time frame: 3 months. Measures at 0,3 months.
description: Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months
measure: concentration of TNF
time frame: 3 months. Measures at 0,3 months.
description: Exercise specific parameters: TNF in Cancer patients (pg/ml) .Measured at baseline, and 3 months
measure: concentration of Interleukins II-1 and II-6
time frame: 3 months. Measures at 0,3 months.
description: Exercise specific parameters: Interleukins II-1 and II-6 (pg/ml). Measured at baseline, and 3 months
measure: Change in Body composition (fat and muscular weight). (BMI)
time frame: 1 year follow up. Measures at 0,3,6 and 12 months
description: Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m^2). Measured at baseline, and 3, 6, 12 months
arm group label: Supervised arm
arm group type: Experimental
description: Supervised exercise. The intervention will be a free 12-week, small-group (~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.
arm group label: Control arm
arm group type: Active Comparator
description: Supervised exercise.The intervention will be a Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation.
After 3 months, it become supervised arm
intervention type: Other
intervention name: Supervised exercise
description: a free 12-week, small-group (~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.
arm group label: Control arm
arm group label: Supervised arm
intervention type: Other
intervention name: Personalized Program PVS
description: a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool "Promote Healthy Living" integrated into the electronic medical record.
arm group label: Control arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nere Mendizabal
role: Principal Investigator
affiliation: Basque Health Service
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Nere Mendizabal
investigator title: Principal Investigator
sharing ipd: No