Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Rate of Satisfaction (Open Pilot only)
研究概览
简要总结
The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT).
详细描述
This research is being done to determine whether a cognitive-behavioral therapy (CBT) for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant.
An open pilot of 6 participants will precede the randomized controlled trial. Study procedures for the open pilot include screening for eligibility, intervention Zoom sessions, questionnaires, and exit interviews with study staff.
Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups: CBT for fatigue intervention versus usual care.Study procedures include screening for eligibility, intervention Zoom sessions (intervention arm) or receipt of informational materials about fatigue (usual care arm), and completion of study questionnaires (after consent but before randomization and at approximately 3 and 5 months post-randomization).
This research study is expected to last about 3 years. It is expected about 66 people will take part in this research study.
The National Heart, Lung, and Blood Institute of the National Institute of Health is providing funding for this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •adult patients (≥ 18 years)
- •have the ability to speak and read English
- •have undergone autologous or allogeneic transplant > 6 months prior to enrollment
- •no evidence of disease relapse requiring therapy
- •no new other malignancy requiring therapy after transplant
- •report moderate to severe fatigue in the past week (FSI average severity item rating ≥ 4 of 0-10)
- •are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
排除标准
- •Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention
- •Patients already receiving CBT care
- •Patients living with untreated sleep apnea
- •Patients with hypoxemia requiring oxygen supplementation
研究组 & 干预措施
CBT for Fatigue Program
Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
- Baseline questionnaires.
- 10 intervention sessions.
- Questionnaires and surveys 3 and 5 months after enrollment.
干预措施: CBT for Fatigue (Behavioral)
Usual Care
Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
- Baseline questionnaires.
- Receive adapted material from the MGH Bone Marrow Transplant Survivorship program outlining common contributors to fatigue after transplant and recommendations for management.
- Questionnaires and surveys 3 and 5 months after enrollment.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Rate of Satisfaction (Open Pilot only)
时间窗: 3 month follow-up
Acceptability is defined by at least 80% of participants reporting satisfaction on the Client Satisfaction Questionnaire (range 8-32, with higher scores representing higher satisfaction).
Rate of Retention
时间窗: Baseline (pre-randomization) up to 5 month follow-up
The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial.
Rate of Intervention Completion
时间窗: Baseline (pre-randomization) up to 3 month follow-up
The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial.
Rate of Enrollment
时间窗: At recruitment
The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.
次要结局
- Improvement of Fatigue(Baseline (pre-randomization) up to 5 month follow-up)
- Improvement of Mood(Baseline (pre-randomization) up to 5 month follow-up)
- Improvement of Quality of Life(Baseline (pre-randomization) up to 5 month follow-up)
研究者
Ashley M. Nelson, PhD
Principal Investigator
Massachusetts General Hospital