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

Institut Paoli-Calmettes

Status: Not yet enrolling

Conditions: Hematological Cancer

Treatments: Other: interviews with coachs, semi-structured interviews and questionnaires; Other: semi-structured interviews and questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05486273

REBOND2-IPC 2022-009

Details and patient eligibility

About

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

Full 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

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Groupe OC (Onco-Coaching)

Experimental group

Description:

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.

Treatment:

Other: interviews with coachs, semi-structured interviews and questionnaires

Groupe C (Contrôle)

Active Comparator group

Description:

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

Treatment:

Other: semi-structured interviews and questionnaires