Clinical trial NCT05486273: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematological Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They will be randomized unequally (2:1) into one of the study groups
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
timeFrame: from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
Secondary outcomes:
measure: To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12).
timeFrame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
measure: Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy).
timeFrame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
measure: Measure the impact of a coaching program on reducing emotional distress.
timeFrame: from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)
measure: Evaluate the cost-utility of the coaching program.
timeFrame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
measure: Assess correlations between quality of life and patient empowerment
timeFrame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
measure: Assess the overall survival of participants
timeFrame: from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli-Calmettes
name: Didier BLAISE, Pr
role: PRINCIPAL_INVESTIGATOR
References: