Multiple Myeloma Clinical Trial
Official title:
A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
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.
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.
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