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

NCT05486273 | Unknown

• 1 other identifier: REBOND2-IPC 2022-009
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hematological Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• 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)

• Measure the impact of a coaching program on reducing emotional distress.

  from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion)

• Evaluate the cost-utility of the coaching program.

  from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)

• Assess correlations between quality of life and patient empowerment

  from inclusion(RO=M3) to R12(Month15 =12 month post inclusion)

Study Arms (2)

Groupe OC (Onco-Coaching)

EXPERIMENTAL

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

Groupe C (Contrôle)

ACTIVE COMPARATOR

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

Interventions

interviews with coachs, semi-structured interviews and questionnaires OTHER

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)

Groupe OC (Onco-Coaching)

semi-structured interviews and questionnaires OTHER

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)

Groupe C (Contrôle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age and have a good understanding and practice of the French language,
• Have been treated by an allogeneic hematopoietic stem cell transplant
• Signed consent to participate,
• Affiliation with a social security plan, or beneficiary of such a plan.

You may not qualify if:

• Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
• Patient with progressive or relapsing hematological disease,
• Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
• Person requiring psychotherapeutic care
• Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Interventions

Interviews as Topic; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Didier BLAISE, Pr

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, Dr

CONTACT

0491223778; drci.up@ipc.unicancer.fr

Allison ARTHUR

CONTACT

0491223448

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: They will be randomized unequally (2:1) into one of the study groups

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 3, 2022
• Study Start: January 2, 2023
• Primary Completion: January 2, 2026
• Study Completion: January 2, 2026
• Last Updated: October 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share