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

NCT ID: NCT05486273

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2026-01-02

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

Conditions

Hematological Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

interviews with coachs, semi-structured interviews and questionnaires

Intervention Type: 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 C (Contrôle)

the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm.

Group Type: ACTIVE_COMPARATOR

semi-structured interviews and questionnaires

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier BLAISE, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Central Contacts

Dominique GENRE, Dr

Role: CONTACT

drci.up@ipc.unicancer.fr

0491223778

Allison ARTHUR

Role: CONTACT

0491223448

Other Identifiers

REBOND2-IPC 2022-009

Identifier Type: -

Identifier Source: org_study_id