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 : a Randomized Controlled Trial REBOND2-IPC 2022-009
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
研究概览
简要总结
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: interviews with coachs, semi-structured interviews and questionnaires (Other)
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.
干预措施: semi-structured interviews and questionnaires (Other)
结局指标
主要结局
To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).
时间窗: from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion)
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
次要结局
- 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))
- Evaluate the cost-utility of the coaching program.(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))
- Assess correlations between quality of life and patient empowerment(from inclusion(RO=M3) to R12(Month15 =12 month post inclusion))
- Assess the overall survival of participants(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))