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/NCT05981170</url>
    </required_header>
    <id_info>
      <org_study_id>ICO-2022-20</org_study_id>
      <nct_id>NCT05981170</nct_id>
    </id_info>
    <brief_title>Rurality Adapted Physical Activity Sport Health</brief_title>
    <acronym>RAPASS</acronym>
    <official_title>To Evaluate the Impact of Home-based Adapted Physical Activity Programme for Patients With Brain Tumours and/or Metastatic Cancer Living in Rural Areas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Cancerologie de l'Ouest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Cancerologie de l'Ouest</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>
        Physical activity (PA) has been an integral part of non-drug therapy since the early 2010s.&#xD;
        This supportive care is likely to reduce fatigue and improve the quality of life of patients&#xD;
        during and after the cancer treatment phase.&#xD;
  &#xD;
        Physical activity also has a protective effect in terms of tertiary prevention by reducing&#xD;
        the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and&#xD;
        by reducing overall mortality.&#xD;
  &#xD;
        Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest (ICO)&#xD;
        in Angers, but there are obstacles particularly linked to the geographical distance of the&#xD;
        establishment where this activity is offered.&#xD;
  &#xD;
        The RAPASS project is a prospective study which will be proposed to patients followed at the&#xD;
        ICO, living in rural areas and far from Angers. Its main objective is to describe the fatigue&#xD;
        and quality of life of patients before, during and after a 13-session home-based APA&#xD;
        programme. The data collected will also be used to describe changes in physical condition and&#xD;
        level, compliance with the programme, continuation of physical activity beyond the duration&#xD;
        of the programme, and satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The oncologist first assesses the patient's need for APA. The patient is then seen by the&#xD;
        ICO's APA coach (EAPA) who presents the APA programme. If the patient agrees to participate,&#xD;
        the coach assesses the patient's physical capacity in order to adapt the programme to their&#xD;
        needs.&#xD;
  &#xD;
        The programme is then carried out with the departmental sports for all committee 49.&#xD;
  &#xD;
        The frequency of practice will ideally be one session per week at the patient's home,&#xD;
        supervised by a coach from Departmental Committee for Sport for All in 49. A total of 13&#xD;
        sessions will be carried out.&#xD;
  &#xD;
        The sessions will aim to develop all the components of physical fitness (endurance, strength,&#xD;
        balance, flexibility, coordination, etc.).&#xD;
  &#xD;
        The patient receives a walking logbook to record the number of daily steps taken, an exercise&#xD;
        booklet to work independently and a pedometer.&#xD;
  &#xD;
        In the presence of the coach, the patients perform different exercises and complete different&#xD;
        questionnaires.&#xD;
  &#xD;
        The programme is evaluated by the ICO EAPA 3 months after the 13th and final session.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)</measure>
      <time_frame>Through study completion, an average 6 months.</time_frame>
      <description>To describe the fatigue (physical, functional, social, emotional components) of patients.&#xD;
  The Score from FACIT-F range from 0 to 52. The higher the score, the lower is the fatigue.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Short Physical Performance Battery test (SPPB)</measure>
      <time_frame>Through studied intervention, an average 3 months.</time_frame>
      <description>It is used to assess the physical performance of an individual. It is the result of the scores of three criteria: the balance test, the walking speed test and the chair lift test.&#xD;
  The sum of the scores of all the tests gives an overall performance score:&#xD;
  SPPB 0-6: Poor performance&#xD;
  SPPB 7-9: Intermediate performance&#xD;
  SPPB 10-12: High performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minute walk test</measure>
      <time_frame>Through studied intervention, an average 3 months.</time_frame>
      <description>This test measures the functional limitation by comparing the theoretical distance with the measured distance. The patient is asked to walk as far as possible within six minutes:&#xD;
  Excellent functional mobility ≥91% of the theoretical distance&#xD;
  Good functional mobility between 82% and 90% of the theoretical distance&#xD;
  Moderate functional limitation between 74% and 82% of the theoretical distance&#xD;
  Severe functional limitation ≤73% of the theoretical distance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand grip test</measure>
      <time_frame>Through studied intervention, an average 3 months.</time_frame>
      <description>This test measures muscular health of the hands and forearms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Flexibility test</measure>
      <time_frame>Through studied intervention, an average 3 months.</time_frame>
      <description>The patient performs a standing trunk flexion with legs stretched. Depending on the area reached (hand touching the ground, kick, tibia, etc.), a score will be given on a scale of 1 to 5, which differs according to the patient's sex.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance test</measure>
      <time_frame>Through studied intervention, an average 3 months.</time_frame>
      <description>The patient is asked to stand on one leg for 1 minute with their eyes open. The best time is recorded and depending on the age and sex of the patient, his or her performance will be rated on a scale of 1 (very poor balance) to 4 (excellent balance).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ricci et Gagnon questionnaire</measure>
      <time_frame>Through study completion, an average 6 months.</time_frame>
      <description>This questionnaire assesses the level of physical activity.&#xD;
  A number of points ranging from 1 to 5 are assigned to each answer. The total sum of the points determines an overall score that classifies the patients into :&#xD;
  Score &lt; 18 : inactive&#xD;
  18 ≤ Score ≤ 35: active&#xD;
  Score &gt; 35: very active</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Global Impression scale (P-GIC)</measure>
      <time_frame>At the end of the APA sessions, on average 3 months</time_frame>
      <description>Evaluates the patient's satisfaction with the implementation of a home-based APA programme.&#xD;
  The questionnaire includes a single question asking the patient what change home-based APA has had on their overall quality of life. The patient is given 7 options from which to choose the one that best corresponds to the perceived change: Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Brain Tumour</condition>
    <condition>Metastatic Cancer</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Adapted physical activity at home</intervention_name>
      <description>The programme will take place over 6 months and will include :&#xD;
  1 consultation with the oncologist who will first assess the need for Adapted Physical Activity and then prescribe the APA with a certificate of no physical contraindication&#xD;
  1 consultation with the ICO's APA coach who will present the APA programme and assess the patient's physical capacity using the Short Physical Performance Battery (SPPB) test in order to adapt the programme to their needs.&#xD;
  13 home-based APA sessions (ideally one session per week) with the EAPA from Departmental Committee for Sport for All in 49&#xD;
  1 telephone call with the EAPA of the ICO to evaluate the programme 3 months after the last session.&#xD;
  Patients will also be asked to complete questionnaires at the first session (S1), halfway through the sessions (S6) and at the last session (S13).&#xD;
  These are FACIT-F 5Functional Assessment of Chronic Illness Therapy - Fatigue ; Ricci and L. Gagnon ; P-GIC (Patients' Global Impression of Change (PGIC) scale)</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated at the ICO Angers for a brain tumour and or metastatic cancer with&#xD;
          medically measured APA needs.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Performans Status ≤ 2&#xD;
  &#xD;
            -  Patient living in a rural area&#xD;
  &#xD;
            -  Patient with a brain tumour and/or metastatic cancer&#xD;
  &#xD;
            -  Patient with a medical prescription for APA practice&#xD;
  &#xD;
            -  Patient with a certificate of no contraindication to physical activity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons deprived of their liberty, under court protection, under guardianship or under&#xD;
               the authority of a guardian&#xD;
  &#xD;
            -  Patient unable to undergo the trial procedures for social or psychological reasons&#xD;
  &#xD;
            -  Patient who does not understand French&#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>Loïc FAIVRE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institut de Cancérologie de l'Ouest</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Loïc FAIVRE</last_name>
      <phone>(0)2 41 35 27 00</phone>
      <phone_ext>+33</phone_ext>
      <email>loïc.faivre@ico.unicancer.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institut de Cancerologie de L'Ouest</name>
        <address>
          <city>Angers</city>
          <zip>49055</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Loïc FAIVRE</last_name>
        <phone>(0)2 41 35 27 00</phone>
        <phone_ext>+33</phone_ext>
        <email>loic.faivre@ico.unicancer.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adapted physical activity</keyword>
    <keyword>Rurality</keyword>
    <keyword>Oncology</keyword>
    <keyword>Physical fitness</keyword>
    <keyword>Supportive care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Neoplasms</mesh_term>
      <mesh_term>Neoplasm Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05981170
  org study id: ICO-2022-20
  nct id: NCT05981170
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Physical activity (PA) has been an integral part of non-drug therapy since the early 2010s.
        This supportive care is likely to reduce fatigue and improve the quality of life of patients
        during and after the cancer treatment phase.
  
        Physical activity also has a protective effect in terms of tertiary prevention by reducing
        the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and
        by reducing overall mortality.
  
        Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest (ICO)
        in Angers, but there are obstacles particularly linked to the geographical distance of the
        establishment where this activity is offered.
  
        The RAPASS project is a prospective study which will be proposed to patients followed at the
        ICO, living in rural areas and far from Angers. Its main objective is to describe the fatigue
        and quality of life of patients before, during and after a 13-session home-based APA
        programme. The data collected will also be used to describe changes in physical condition and
        level, compliance with the programme, continuation of physical activity beyond the duration
        of the programme, and satisfaction.
  The oncologist first assesses the patient's need for APA. The patient is then seen by the
        ICO's APA coach (EAPA) who presents the APA programme. If the patient agrees to participate,
        the coach assesses the patient's physical capacity in order to adapt the programme to their
        needs.
  
        The programme is then carried out with the departmental sports for all committee 49.
  
        The frequency of practice will ideally be one session per week at the patient's home,
        supervised by a coach from Departmental Committee for Sport for All in 49. A total of 13
        sessions will be carried out.
  
        The sessions will aim to develop all the components of physical fitness (endurance, strength,
        balance, flexibility, coordination, etc.).
  
        The patient receives a walking logbook to record the number of daily steps taken, an exercise
        booklet to work independently and a pedometer.
  
        In the presence of the coach, the patients perform different exercises and complete different
        questionnaires.
  
        The programme is evaluated by the ICO EAPA 3 months after the 13th and final session.
  observational model: Cohort
  time perspective: Prospective
  measure: Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
  time frame: Through study completion, an average 6 months.
  description: To describe the fatigue (physical, functional, social, emotional components) of patients.
  The Score from FACIT-F range from 0 to 52. The higher the score, the lower is the fatigue.
  measure: Short Physical Performance Battery test (SPPB)
  time frame: Through studied intervention, an average 3 months.
  description: It is used to assess the physical performance of an individual. It is the result of the scores of three criteria: the balance test, the walking speed test and the chair lift test.
  The sum of the scores of all the tests gives an overall performance score:
  SPPB 0-6: Poor performance
  SPPB 7-9: Intermediate performance
  SPPB 10-12: High performance
  measure: 6 minute walk test
  time frame: Through studied intervention, an average 3 months.
  description: This test measures the functional limitation by comparing the theoretical distance with the measured distance. The patient is asked to walk as far as possible within six minutes:
  Excellent functional mobility ≥91% of the theoretical distance
  Good functional mobility between 82% and 90% of the theoretical distance
  Moderate functional limitation between 74% and 82% of the theoretical distance
  Severe functional limitation ≤73% of the theoretical distance
  measure: Hand grip test
  time frame: Through studied intervention, an average 3 months.
  description: This test measures muscular health of the hands and forearms.
  measure: Flexibility test
  time frame: Through studied intervention, an average 3 months.
  description: The patient performs a standing trunk flexion with legs stretched. Depending on the area reached (hand touching the ground, kick, tibia, etc.), a score will be given on a scale of 1 to 5, which differs according to the patient's sex.
  measure: Balance test
  time frame: Through studied intervention, an average 3 months.
  description: The patient is asked to stand on one leg for 1 minute with their eyes open. The best time is recorded and depending on the age and sex of the patient, his or her performance will be rated on a scale of 1 (very poor balance) to 4 (excellent balance).
  measure: Ricci et Gagnon questionnaire
  time frame: Through study completion, an average 6 months.
  description: This questionnaire assesses the level of physical activity.
  A number of points ranging from 1 to 5 are assigned to each answer. The total sum of the points determines an overall score that classifies the patients into :
  Score < 18 : inactive
  18 ≤ Score ≤ 35: active
  Score > 35: very active
  measure: The Patient Global Impression scale (P-GIC)
  time frame: At the end of the APA sessions, on average 3 months
  description: Evaluates the patient's satisfaction with the implementation of a home-based APA programme.
  The questionnaire includes a single question asking the patient what change home-based APA has had on their overall quality of life. The patient is given 7 options from which to choose the one that best corresponds to the perceived change: Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
  intervention type: Other
  intervention name: Adapted physical activity at home
  description: The programme will take place over 6 months and will include :
  1 consultation with the oncologist who will first assess the need for Adapted Physical Activity and then prescribe the APA with a certificate of no physical contraindication
  1 consultation with the ICO's APA coach who will present the APA programme and assess the patient's physical capacity using the Short Physical Performance Battery (SPPB) test in order to adapt the programme to their needs.
  13 home-based APA sessions (ideally one session per week) with the EAPA from Departmental Committee for Sport for All in 49
  1 telephone call with the EAPA of the ICO to evaluate the programme 3 months after the last session.
  Patients will also be asked to complete questionnaires at the first session (S1), halfway through the sessions (S6) and at the last session (S13).
  These are FACIT-F 5Functional Assessment of Chronic Illness Therapy - Fatigue ; Ricci and L. Gagnon ; P-GIC (Patients' Global Impression of Change (PGIC) scale)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Loïc FAIVRE
  role: Principal Investigator
  affiliation: Institut de Cancérologie de l'Ouest
  last name: Loïc FAIVRE
  phone: (0)2 41 35 27 00
  phone ext: +33
  email: loïc.faivre@ico.unicancer.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Brain Neoplasms
  mesh term: Neoplasm Metastasis
  sharing ipd: No