Return to Everyday Life After Non-myeloablative Allogeneic Haematopoietic Stem Cell Transplantation; Feasibility and Participants' Perspectives of a Targeted Multimodal Interdisciplinary Rehabilitation Programme (HAPPY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exposure to individual dialogues
研究概览
简要总结
Non-myeloablative allogeneic haematopoietic stem cell transplantation (NMA-HSCT) is associated with innumerable complications and side-effects and a high treatment-related mortality. Maintaining quality of life, physical and psychosocial functioning and participation in society is therefore challenging for patients undergoing treatment with NMA-HSCT. This situation creates an urgent need for rehabilitation for patients to return to a meaningful everyday life, and for knowledge about how to best help this group of patients return to everyday life.
The project aims to develop and examine the feasibility and safety of a multimodal interdisciplinary rehabilitation programme targeted patients undergoing treatment with NMA-HSCT.
Three studies are planned. Study I is a qualitative interview study to get a profound insight into patients' experiences and challenges after NMA-HSCT.
Study II has a single arm longitudinal design with both a feasibility and an outcome component. Patients (N=30) are consecutively recruited at the Department of Haematology, Aarhus University Hospital, Denmark and enrolled in the 6-month HAPPY programme as soon as the decision about NMA-HSCT is final. Data is collected pre-NMA-HSCT, at 3-month, 6-month and 12-month after NMA-HSCT.
Study III is a qualitative interview study, where patients who participated in the rehabilitation programme evaluate the programme's influence on their return to everyday life.
The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases. We will document the impact of an interdisciplinary intervention anchored in the hospital setting but aimed at reaching patients at home. If the intervention enhances quality of life, patient activation and functioning, it may not only reduce the number of hospitalizations and use of healthcare services, but may also allow more patients to maintain contact with the labour market and resume participation in society.
详细描述
Rehabilitation is becoming increasingly important in the face of growing diversity and intensity of cancer treatment and so is treatment with haematopoietic stem cell transplantation from a donor. Non-myeloablative allogeneic haematopoietic stem cell transplantation (NMA-HSCT) is associated with innumerable complications and side-effects and a high treatment-related mortality. Maintaining quality of life, physical and psychosocial functioning, and participation in society is therefore challenging for patients undergoing treatment with NMA-HSCT. This situation creates an urgent need for rehabilitation for patients to return to a meaningful everyday life, and for knowledge about how to best support this group of patients' return to everyday life.
The overall aim is to develop and evaluate the feasibility of a targeted multimodal interdisciplinary rehabilitation programme by involving patients undergoing NMA-HSCT.
Three studies were planned in accordance with the theoretical framework of Complex Interventions.
Study I is a qualitative focus group interview study using the Interpretive Description methodology. The purpose was to explore the experiences and perspectives of NMA-HSCT patients regarding their challenges and needs during their return to everyday life after HSCT transplantation.
Study II has a single arm longitudinal design with both a feasibility component and an outcome component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients were accepted for NMA-HSCT
- •≥ 18 years
- •able to read and understand Danish and to follow the study protocol.
排除标准
- •psychological diagnosis
- •contra-indications for progressive exercise training
- •inability to walk or stand
- •instable bone lesions
- •severe neurological deficiencies
- •severe cardiac or cardio vascular diseases, severe pulmonary global insufficiency.
研究组 & 干预措施
HAPPY
Single arm longitudinal design.
干预措施: Multimodal interdisciplinary rehabilitation programme (HAPPY) (Other)
结局指标
主要结局
Exposure to individual dialogues
时间窗: Baseline - 6-month follow-up
The percentage of individual dialogues with fixed subjects used by the patients out all planned, and reason(s) for non-participation
Recruitment rate
时间窗: Baseline - 6-month follow-up
Number of patients who accepted to participate in the study out of patients treated with non-myeloablative allogeneic haematopoietic stem cell transplantation
Exposure to physical exercise training per patient
时间窗: Baseline - 6-month follow-up
The percentage of physical exercise training used by the patients when he/she was at the hospital and reason(s) for non-participation
Exposure to group sessions topics together with fellow patients and relatives per patient
时间窗: Baseline - 6-month follow-up
The percentage of group sessions with different topics used by the patients out all planned, and reason(s) for non-participation
Exposure to nutritional counselling per patient
时间窗: Baseline - 6-month follow-up
The percentage of nutritional counselling used by the patients out of planned, and reason(s) for non-participation
Exposure to phone calls to patients staying at home
时间窗: Baseline - 6-month follow-up
The percentage use of phone calls by patients while they stay at home, and reason(s) for unused
Attrition and reasons for drop out
时间窗: Baseline - 6-month follow-up
Number of drop-outs of patients participating in the study
Exposure to motivating interviewing per patient
时间窗: Baseline - 6-month follow-up
The percentage of motivating interviewing used by the patients out all planned, and reason(s) for non-participation
Exposure to digital physical exercise programme per patient
时间窗: Baseline - 6-month follow-up
The percentage usage of the digital exercise programme out of possible/planned digital exercise trainings, and reason(s) for non-participation
Adverse Events
时间窗: Baseline-1-year follow-up
The number of adverse events related to the intervention
次要结局
- Fidelity of physical exercise training(Baseline - 6-month follow-up)
- Fidelity of motivating interviewing(Baseline - 6-month follow-up)
- Fidelity of individual dialogues(Baseline - 6-month follow-up)
- Fidelity of group sessions(Baseline - 6-month follow-up)
- Practicability of questionnaires and physical tests(Baseline-1-year follow-up)
- Fidelity of nutritional counselling(Baseline - 6-month follow-up)
- Fidelity of delivered phone calls(Baseline - 6-month follow-up)
- Fidelity of the digital exercise programme(Baseline - 6-month follow-up)