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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