Hematological Cancer
Conditions
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
Interventions
OTHERinterviews 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)
OTHERsemi-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)
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
They will be randomized unequally (2:1) into one of the study groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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( Month 15 =12 month post inclusion) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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(Month15 =12 month post inclusion) | 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. | from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion) | 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 |
| 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(Month15 =12 month post inclusion) | 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 |
| Assess correlations between quality of life and patient empowerment | from inclusion(RO=M3) to R12(Month15 =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(Month15 =12 month post inclusion) | measure the overall survival rate at M15/R12 |
| Evaluate the cost-utility of the coaching program. | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) | incremental cost-effectiveness ratio (QALYs) |
Contacts
Primary ContactDominique GENRE, Dr
Backup ContactAllison ARTHUR
Outcome results
None listed