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
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Groupe OC (Onco-Coaching) 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. |
Other: interviews with coachs, semi-structured interviews and questionnaires
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)
|
| Active Comparator: Groupe C (Contrôle) the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm. |
Other: semi-structured interviews and questionnaires
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)
|
Outcome Measures
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). [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
evolution over time of the FACT-BMT score during the first 15 months after transplantation
Secondary Outcome Measures
- To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12). [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
evolution of the FACT-BMT 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
- Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy). [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
evolution over time of self-efficacy, capability, subjective well-being and hope scores
- Measure the impact of a coaching program on reducing emotional distress. [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
changes over time in HADS scores
- Evaluate the cost-utility of the coaching program. [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
incremental cost-effectiveness ratio (QALYs)
- Assess correlations between quality of life and patient empowerment [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
evolution over time of the patient's speech (semi-directive interviews)
- Assess the overall survival of participants [from inclusion(RO=M3) to R12(Mois 15 =12 month post inclusion)]
measure the overall survival rate at M15/R12
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be at least 18 years of age and have a good understanding and practice of the French language,
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Have been treated by an allogeneic hematopoietic stem cell transplant
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Signed consent to participate,
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Affiliation with a social security plan, or beneficiary of such a plan.
Exclusion Criteria:
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Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
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Patient with progressive or relapsing hematological disease,
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Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
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Person requiring psychotherapeutic care
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Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Paoli-Calmettes
Investigators
- Principal Investigator: Didier BLAISE, Pr, Institut Paoli-Calmettes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REBOND2-IPC 2022-009