Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (allo-HSC) is currently one of the only curative treatments for haematological malignancies with a poor prognosis, the realization of which presupposes the identification and availability of a compatible donor. In recent years, haploidentical transplants have been developed, a reliable alternative for patients who do not have 100% compatible donors.
The development of haplo-identical transplants leads to an exponential increase in the use of intra-family donation. Intrafamilial donation of hematopoietic stem cells (HSC) has the advantages of lower financial cost and faster availability of the graft, thus avoiding the risk of relapse before the procedure. Nevertheless, intrafamilial donation raises clinical and ethical questions. Indeed, the psychological impact of intra-family donation on the donor cannot be overlooked. Thus, in the context of the development of haplo-identical transplants, measuring the impact of donation on donors (ascendants and descendants) will make it possible to assess the relevance of taking psychosocial aspects into consideration in the choice of donors, to assess the psychological impact of haplo-identical donation and to offer psychological support adapted to donors.
详细描述
This is a prospective, exploratory and bicentric study with a quantitative and qualitative approach, with the aim of exploring the psychosocial aspects of the experience of haplo-identical transplantation in adult HSC donors for transplantation. haplo-identical for their children or for their parents.
For this, the evolution of the anxiety and depression) of the donors will be evaluated on D0, D90, D180 and D360 post donation, thanks to State-Trait anxiety Inventory questionnaire, Center for Epidemiologic Studies Depression Scale and by the 12-Item Short Form Health Survey;
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
- 是
入选标准
- •Identical haplo CSH donors ascending (parents) or descending (children)
- •Major identical haplo HSC donors
- •Haplo-identical HSC donors living in mainland France and cared for in the centers participating in the study
- •Haplo-identical HSC donors benefiting from Social Security System.
- •Haplo-identical HSC donors who have signed the consent form
- •- Ability to read and write in French
排除标准
- •Insufficient understanding of the French language
研究组 & 干预措施
HSC donors
Completion of questionnaires + socio-demographic data
干预措施: Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft. (Other)
结局指标
主要结局
Anxiety
时间窗: D0 ; D90, D180 and D360
Assessed by the State-Trait anxiety Inventory (STAI-Y), self-questionnaire validated in French STAI-Y : Spielberger trait anxiety questionnaire minimum value : almost never maximum value : almost always Higher score = better outcome
次要结局
- Describe the donor management methods(Day 0)
- Describe medical events in patients and assess the impact on the donor's mental state(Day 360)
- Quality of donor's life(Day 360)
- Family functioning(Day 360)
- Describe the medical problems encountered since the donation of HSCs(Day 360)
- Describe the medical events concerning the donation of CSH(Day 360)
- Depression(Day 360)
- Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs(Day 90)
- Evaluate the donors' perception of the care offered to them(Day 360)