NCT02955043

Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hodgkin Lymphoma
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Lymphoid Leukemia
• Myeloid Leukemia
• Myelodysplastic Syndromes
• Multiple Myeloma

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral techniques	Improve nighttime sleep: Participants will receive a modified form of cognitive-behavioral therapy for insomnia with a primary focus on stimulus control, a set of techniques to strengthen the association between bed and sleep and weaken its association with stimulating behaviors. Increase daytime activity: Participants will receive instruction in activity management strategies including prioritizing activities, planning activities during peak energy, activity pacing, and alternating between rest and activity. Participants will be provided with a basic step-count pedometer to enhance ability to self-monitor activity and increase motivation for activity. The intervention will be adapted to individual needs based on assessments of sleep and activity patterns.

Timeline

• Start date: 2016-12-22
• Primary completion: 2018-10-26
• Completion: 2018-10-26
• First posted: 2016-11-04
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States