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

Hematological Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486273
• Other study ID #: REBOND2-IPC 2022-009
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: January 2, 2026

Study information

• Verified date: August 2022
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, Dr
• Phone: 0491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: January 2, 2026
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematological Cancer
• Respiratory Aspiration

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
Secondary	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	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Secondary	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	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Secondary	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	from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)
Secondary	Evaluate the cost-utility of the coaching program.	incremental cost-effectiveness ratio (QALYs)	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Secondary	Assess correlations between quality of life and patient empowerment	evolution over time of the patient's speech (semi-directive interviews)	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
Secondary	Assess the overall survival of participants	measure the overall survival rate at M15/R12	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)