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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hematological Cancer
• Intervention / Treatment: Other: interviews with coachs, semi-structured interviews and questionnaires; Other: semi-structured interviews and questionnaires

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

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique GENRE, Dr; Phone Number: 0491223778; Email: drci.up@ipc.unicancer.fr
• Study Contact Backup: Name: Allison ARTHUR; Phone Number: 0491223448

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Evaluate the cost-utility of the coaching program.	incremental cost-effectiveness ratio (QALYs)	from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)
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)
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)

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Didier BLAISE, Pr, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Anticipated): January 2, 2023
• Primary Completion (Anticipated): January 2, 2026
• Study Completion (Anticipated): January 2, 2026

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: REBOND2-IPC 2022-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No