Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of patients with all the navigation nurse intervention files received at 100%
研究概览
简要总结
After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients over 18 years of age
- •Having received an allogeneic hematopoietic stem-cell transplant
- •In full remission
- •Outpatients
- •Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months
- •Affiliated with the social security system
排除标准
- •Transplant patients not having given their informed consent for inclusion in AMA-ALLO
- •Hospitalized or non-outpatient transplant patients
- •Post-transplant patients in cytological relapse
- •Patients under a legal regime of adult protection (guardianship, curatorship, etc.)
结局指标
主要结局
Rate of patients with all the navigation nurse intervention files received at 100%
时间窗: 12 months
Rate of patients with all the navigation nurse intervention files received at 100%. A file is received at 100% if the 4 following tasks are fully completed: 1. - patient called by nurse (and response from the patient at the set telephone appointment) 2. - completion of medical-psycho-social questionnaire (AMA-ALLO phone call form) by nurse with the patient's responses 3. - information and transmission of questionnaire results by nurse to the transplant physician 4. - physician/nurse decision for potential intervention (specialized consultation, consultation with the transplant physician, hospitalization, modification of treatments, additional exams to carry out, etc.)
次要结局
- Rate of ineligibility of the navigation nurse intervention files(12 months)
- Quality of life for transplant patients(12 months)
- Rate of refusal for participation in the study(12 months)