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Trial 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

NCT ID: NCT05486273

Condition: Hematological Cancer

Conditions: Official terms:
Respiratory Aspiration

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: They will be randomized unequally (2:1) into one of the study groups

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: interviews with coachs, semi-structured interviews and questionnaires
Description: 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)
Arm group label: Groupe OC (Onco-Coaching)

Intervention type: Other
Intervention name: semi-structured interviews and questionnaires
Description: 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)
Arm group label: Groupe C (ContrĂ´le)

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 2, 2023

Completion date: January 2, 2026

Lead sponsor:
Agency: Institut Paoli-Calmettes
Agency class: Other

Source: Institut Paoli-Calmettes

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05486273

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