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Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells

Primary Purpose

Hematological Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interviews with coachs, semi-structured interviews and questionnaires
semi-structured interviews and questionnaires
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematological Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be at least 18 years of age and have a good understanding and practice of the French language,
  2. Have been treated by an allogeneic hematopoietic stem cell transplant
  3. Signed consent to participate,
  4. Affiliation with a social security plan, or beneficiary of such a plan.

Exclusion Criteria:

  1. Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
  2. Patient with progressive or relapsing hematological disease,
  3. Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
  4. Person requiring psychotherapeutic care
  5. Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Groupe OC (Onco-Coaching)

    Groupe C (Contrôle)

    Arm Description

    You will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study. The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit). They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program.

    the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm.

    Outcomes

    Primary Outcome Measures

    To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
    evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200

    Secondary Outcome Measures

    To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12).
    evolution of the FACT-BMT(Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score up to R12 evolution over time of sub-scores related to physical well-being, social well-being, functional well-being and relationship with the physician.the quality of life is a questionnaire with scores ranging from 5 to 20
    Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy).
    evolution over time of self-efficacy (the higher the score, the better the efficiency), capability, subjective well-being and hope scores
    Measure the impact of a coaching program on reducing emotional distress.
    changes over time in HADS scores (Hospital Anxiety and Depression Scale)the highest score corresponds to high anxiety and depression the value are between 0 and 21 but if the patient has a score higher than 11, he is suffering from anxiety or depression
    Evaluate the cost-utility of the coaching program.
    incremental cost-effectiveness ratio (QALYs)
    Assess correlations between quality of life and patient empowerment
    evolution over time of the patient's speech (semi-directive interviews)
    Assess the overall survival of participants
    measure the overall survival rate at M15/R12

    Full Information

    First Posted
    July 28, 2022
    Last Updated
    October 24, 2022
    Sponsor
    Institut Paoli-Calmettes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05486273
    Brief Title
    Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells
    Official Title
    Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells : a Randomized Controlled Trial REBOND2-IPC 2022-009
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2, 2023 (Anticipated)
    Primary Completion Date
    January 2, 2026 (Anticipated)
    Study Completion Date
    January 2, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
    Detailed Description
    After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups: OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematological Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    They will be randomized unequally (2:1) into one of the study groups
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Groupe OC (Onco-Coaching)
    Arm Type
    Experimental
    Arm Description
    You will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study. The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit). They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program.
    Arm Title
    Groupe C (Contrôle)
    Arm Type
    Active Comparator
    Arm Description
    the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm.
    Intervention Type
    Other
    Intervention Name(s)
    interviews with coachs, semi-structured interviews and questionnaires
    Intervention Description
    You will be offered 6 coaching sessions at a rate of one session per month and the first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12. Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)
    Intervention Type
    Other
    Intervention Name(s)
    semi-structured interviews and questionnaires
    Intervention Description
    The first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12.Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)
    Primary Outcome Measure Information:
    Title
    To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
    Description
    evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200
    Time Frame
    from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
    Secondary Outcome Measure Information:
    Title
    To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12).
    Description
    evolution of the FACT-BMT(Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score up to R12 evolution over time of sub-scores related to physical well-being, social well-being, functional well-being and relationship with the physician.the quality of life is a questionnaire with scores ranging from 5 to 20
    Time Frame
    from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
    Title
    Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy).
    Description
    evolution over time of self-efficacy (the higher the score, the better the efficiency), capability, subjective well-being and hope scores
    Time Frame
    from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
    Title
    Measure the impact of a coaching program on reducing emotional distress.
    Description
    changes over time in HADS scores (Hospital Anxiety and Depression Scale)the highest score corresponds to high anxiety and depression the value are between 0 and 21 but if the patient has a score higher than 11, he is suffering from anxiety or depression
    Time Frame
    from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)
    Title
    Evaluate the cost-utility of the coaching program.
    Description
    incremental cost-effectiveness ratio (QALYs)
    Time Frame
    from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
    Title
    Assess correlations between quality of life and patient empowerment
    Description
    evolution over time of the patient's speech (semi-directive interviews)
    Time Frame
    from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
    Title
    Assess the overall survival of participants
    Description
    measure the overall survival rate at M15/R12
    Time Frame
    from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be at least 18 years of age and have a good understanding and practice of the French language, Have been treated by an allogeneic hematopoietic stem cell transplant Signed consent to participate, Affiliation with a social security plan, or beneficiary of such a plan. Exclusion Criteria: Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily Patient with progressive or relapsing hematological disease, Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent, Person requiring psychotherapeutic care Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE, Dr
    Phone
    0491223778
    Email
    drci.up@ipc.unicancer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Allison ARTHUR
    Phone
    0491223448
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Didier BLAISE, Pr
    Organizational Affiliation
    Institut Paoli-Calmettes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells

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