xml: <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/NCT06012253</url>
    </required_header>
    <id_info>
      <org_study_id>&quot;70904504/376&quot;</org_study_id>
      <nct_id>NCT06012253</nct_id>
    </id_info>
    <brief_title>The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life</brief_title>
    <official_title>The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life in Patients Receiving Taxane and Platinum-Based Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akdeniz University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akdeniz University Hospital</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>
        The study aims to evaluate the effect of home-based walking program on peripheral neuropathy,&#xD;
        fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.&#xD;
  &#xD;
        The study was designed as a randomized controlled trial. This study will be carried out with&#xD;
        a total of 86 cancer patients receiving taxane and platinum-based chemotherapy, 43 of whom&#xD;
        were in the intervention group and 43 in the control group, whose treatment was started in&#xD;
        Akdeniz University Hospital.&quot;Home Based Walking Program&quot; will be applied to the patients in&#xD;
        the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program,&#xD;
        face-to-face patient education, patient education booklet, sending text messages,&#xD;
        face-to-face and telephone counseling were planned.&#xD;
  &#xD;
        Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short&#xD;
        Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale,&#xD;
        EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC&#xD;
        QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>
      <intervention_model_description>This is a randomized controlled trial consisting of two groups: experimental and control</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Single Blind (Participant, Outcomes Assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire (IPAQ- Short Form)</measure>
      <time_frame>Baseline and 8th week</time_frame>
      <description>It is used to evaluate physical activity. The form includes walking, moderate and vigorous activity, sitting categories. The total score includes the sum of time (minutes) and frequency (days).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria</measure>
      <time_frame>Baseline and 8th week</time_frame>
      <description>This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cancer Fatigue Scale</measure>
      <time_frame>Baseline and 8th week</time_frame>
      <description>This scale was developed to evaluate the fatigue of cancer patients. It includes 15 questions and three sub-dimensions: Physical, Affective and Cognitive. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)</measure>
      <time_frame>Baseline and 8th week</time_frame>
      <description>This scale was developed to evaluate the effect of peripheral neuropathy on quality of life of cancer patients. It includes 20 questions and three sub-dimensions: Sensory, Motor and Autonomic. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of symptoms and problems related to peripheral neuropathy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
      <time_frame>Baseline and 8th week</time_frame>
      <description>This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: Global health status, Functional, Symptom. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Chemotherapeutic Toxicity</condition>
    <arm_group>
      <arm_group_label>Home Based Walking Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will be given the &quot;Ministry of Health Physical Activity Guidelines&quot;.Routine care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Home Based Walking Program</intervention_name>
      <description>The intervention group will be applied to &quot;Home Based Walking Program&quot;. It was aimed that the patients should do at least 150 minutes of moderate-intensity physical exercise per week for up to 8 weeks. The content of the program includes a walking information booklet (information notes, activity chart and obstacle avoidance form), exercise diary, face-to-face-telephone counseling, sending text messages, prepared in line with international guides. It was planned to give weekly counseling to the patients included in the intervention group for an 8-week period.</description>
      <arm_group_label>Home Based Walking Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  18 Years and older (Adult, Older Adult )&#xD;
  &#xD;
            -  Turkish speaking-understanding ability and literate.&#xD;
  &#xD;
            -  Orientation (person, place, time)&#xD;
  &#xD;
            -  Receiving taxane and platinum-based chemotherapy treatment (monotherapy or combined).&#xD;
  &#xD;
            -  Receiving chemotherapy treatment for the first time.&#xD;
  &#xD;
            -  The primary medical diagnosis is cancer (breast cancer, colorectal cancers and other&#xD;
               cancers).&#xD;
  &#xD;
            -  Not having health problems that prevent walking.&#xD;
  &#xD;
            -  Agreeing to participate in the research.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Being bone and brain metastases&#xD;
  &#xD;
            -  Being peripheral neuropathy due to reasons other than chemotherapy (such as chronic&#xD;
               disease, diabetes mellitus, nutritional disorders)&#xD;
  &#xD;
            -  Skin sensitivity on the hands and feet&#xD;
  &#xD;
            -  Having cardiovascular, pulmonary, musculoskeletal, or psychological disorders that&#xD;
               limit exercise or mobility&#xD;
  &#xD;
            -  Being in another supportive program&#xD;
  &#xD;
            -  Being in the very active category according to the &quot;International Physical Activity&#xD;
               Scale (IPAQ- Short Form)&quot;&#xD;
  &#xD;
            -  Being a severity of more than 4 points according to the &quot;Modified Borg Scale (MBS)&quot;&#xD;
  &#xD;
            -  Being a score of 2 and above according to the &quot;ECOG Performance Scale&quot;&#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>Fatma Arikan, PhD, RN</last_name>
      <role>Study Director</role>
      <affiliation>Akdeniz University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hava Kara</last_name>
      <phone>+905547267943</phone>
      <email>bilgin008@hotmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Akdeniz University</investigator_affiliation>
      <investigator_full_name>Hava Kara</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Home-based walking program</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Cancer</keyword>
    <keyword>Peripheral neuropathy</keyword>
    <keyword>Fatigue</keyword>
    <keyword>Quality of life</keyword>
    <keyword>Nurse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012253
  org study id: "70904504/376"
  nct id: NCT06012253
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to evaluate the effect of home-based walking program on peripheral neuropathy,
        fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.
  
        The study was designed as a randomized controlled trial. This study will be carried out with
        a total of 86 cancer patients receiving taxane and platinum-based chemotherapy, 43 of whom
        were in the intervention group and 43 in the control group, whose treatment was started in
        Akdeniz University Hospital."Home Based Walking Program" will be applied to the patients in
        the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program,
        face-to-face patient education, patient education booklet, sending text messages,
        face-to-face and telephone counseling were planned.
  
        Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short
        Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale,
        EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC
        QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomized controlled trial consisting of two groups: experimental and control
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  masking description: Single Blind (Participant, Outcomes Assessor)
  measure: International Physical Activity Questionnaire (IPAQ- Short Form)
  time frame: Baseline and 8th week
  description: It is used to evaluate physical activity. The form includes walking, moderate and vigorous activity, sitting categories. The total score includes the sum of time (minutes) and frequency (days).
  measure: National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria
  time frame: Baseline and 8th week
  description: This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.
  measure: Cancer Fatigue Scale
  time frame: Baseline and 8th week
  description: This scale was developed to evaluate the fatigue of cancer patients. It includes 15 questions and three sub-dimensions: Physical, Affective and Cognitive. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of fatigue.
  measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
  time frame: Baseline and 8th week
  description: This scale was developed to evaluate the effect of peripheral neuropathy on quality of life of cancer patients. It includes 20 questions and three sub-dimensions: Sensory, Motor and Autonomic. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of symptoms and problems related to peripheral neuropathy.
  measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  time frame: Baseline and 8th week
  description: This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: Global health status, Functional, Symptom. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life.
  arm group label: Home Based Walking Program
  arm group type: Experimental
  description: Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life
  arm group label: Control group
  arm group type: No Intervention
  description: The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.
  intervention type: Other
  intervention name: Home Based Walking Program
  description: The intervention group will be applied to "Home Based Walking Program". It was aimed that the patients should do at least 150 minutes of moderate-intensity physical exercise per week for up to 8 weeks. The content of the program includes a walking information booklet (information notes, activity chart and obstacle avoidance form), exercise diary, face-to-face-telephone counseling, sending text messages, prepared in line with international guides. It was planned to give weekly counseling to the patients included in the intervention group for an 8-week period.
  arm group label: Home Based Walking Program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fatma Arikan, PhD, RN
  role: Study Director
  affiliation: Akdeniz University
  last name: Hava Kara
  phone: +905547267943
  email: bilgin008@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Akdeniz University
  investigator full name: Hava Kara
  investigator title: Principal Investigator
  mesh term: Peripheral Nervous System Diseases
  mesh term: Fatigue