A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Ability to collect complete data from participants
研究概览
简要总结
The goal of this project is to conduct a pilot randomized clinical trial (RCT) to evaluate the feasibility of a brief, behavioral intervention to improve recovery following hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression. If the intervention demonstrates evidence of feasibility and acceptability, a future study will test the effects in a larger trial, with the long-term goal of improving the care and quality of life of cancer survivors recovering from HSCT.
详细描述
Hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT) frequently experience physical and psychological sequelae that impair their quality of life and undermine recovery. Findings from the investigators' laboratory and others indicate that insomnia, fatigue, and depression are among the most persistent, distressing, and debilitating quality-of-life concerns after HSCT. These symptoms co-occur as a "cluster" among cancer patients. Modifying sleep and circadian rest-activity patterns has been suggested to be a particularly promising intervention strategy for alleviating this symptom cluster. The proposed project will therefore evaluate the feasibility and acceptability of a biobehavioral intervention to alleviate insomnia, fatigue, and depression by optimizing sleep and rest-activity patterns during the first 4 months following HSCT. Evidence-based behavioral strategies to enhance the quality of nighttime sleep and increase engagement in non-sedentary daytime activity will be combined to optimize 24-hour rest-activity patterns. These non-pharmacologic approaches can be taught in a few brief sessions and will be delivered in an individual format tailored to each patient.
The investigators have already refined the intervention based on preliminary feasibility testing in a small sample of HSCT recipients and are now conducting a pilot RCT to compare the refined intervention with usual care among adults recovering from HSCT. Semi-structured interviews will determine participant satisfaction with and acceptability of the intervention. Proposed outcome assessments will also be piloted, including patient-reported fatigue, depression, and insomnia measures and actigraphy assessments. The primary goal is to evaluate the feasibility and acceptability of the intervention. The exploratory goal is to conduct a preliminary test of the efficacy of the intervention to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC)
- •Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types)
- •Allogeneic transplant recipients hospitalized for at least 10 days will also be eligible to participate
- •Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so
排除标准
- •Autologous transplant recipients with diagnoses other than multiple myeloma or lymphoma
- •Allogeneic transplant recipients hospitalized for less than 10 days (a small proportion of allogeneic transplant recipients at UWCCC) will be excluded.
结局指标
主要结局
Ability to collect complete data from participants
时间窗: 18 weeks post-transplant
Ability to collect complete data from participants will be evaluated by examining rates of completion of study assessments.
Participant willingness to be randomized and acceptability of the usual care condition
时间窗: 18 weeks post-transplant
Participant willingness to be randomized and acceptability of the usual care condition will be evaluated by examining responses to a semi-structured interview of usual care participants at 18 weeks post-transplant.
Satisfaction with and acceptability of the behavioral techniques
时间窗: 12 weeks post-transplant
To examine intervention uptake, participants will complete daily checklist to indicate which intervention strategies they tried between the initial and final intervention sessions.
Acceptability of the assessment strategy
时间窗: 18 weeks post-transplant
Acceptability of the assessment strategy will be evaluated by examining participant responses to a semi-structured interview at 18 weeks post-transplant.
Ability to recruit patients
时间窗: At the time eligible patients are approached to explain study, up to 20 minutes
Ability to recruit patients will be evaluated by examining reasons for non-participation.
Ability to retain participants
时间窗: 18 weeks post-transplant
Ability to retain participants will be will be evaluated by tracking retention rates through the 18-week study period.
Validity of the assessment strategy
时间窗: 18 weeks post-transplant
To address validity, the ability to predict PROMIS measures with the legacy measures the investigators have previously used successfully with this patient population will be assessed. Strong prediction will imply that the PROMIS measures are a statistically valid approach to quantifying the effects of the intervention.
次要结局
- NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance(Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant)
- NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue(Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant)
- NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression(Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant)
- Actigraphy indices(Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant)