A Behavioral Intervention to Improve Symptoms After Hematopoietic Cell Transplantation.

CONTEXT: Fatigue, insomnia, and depression are persistent, burdensome symptoms for patients recovering from hematopoietic cell transplantation (HCT). Restoring Sleep and Energy after Transplant (ReSET) is a novel behavioral intervention designed to alleviate these symptoms by optimizing patients' 24-hour rest-activity patterns.

OBJECTIVES

The primary aim was to evaluate the feasibility and acceptability of ReSET. An exploratory aim was to determine preliminary effect sizes.

METHODS

This pilot randomized controlled trial compared ReSET to usual care. Participants randomized to ReSET completed three in-person intervention sessions at approximately 3-4, 8, and 12 weeks post-HCT that focused on strategies to improve nighttime sleep and increase nonsedentary daytime activity. All participants wore an actigraphy device (Philips) and completed patient-reported outcome measures (PROMIS sleep disturbance, fatigue, and depression) pre-HCT (T0), 9 (T1), and 18 weeks post-HCT (T2). Interviews were conducted at T2. Ability to recruit, retain, and collect complete data from participants and participant engagement with the intervention were the primary measures of feasibility and acceptability. Interviews were conducted at T2 to provide supplementary insight regarding participant satisfaction and barriers to completion.

RESULTS

Thirty-nine patients were randomized, and most (n = 35; 89.7%) completed the study. Most ReSET participants (85%) completed all intervention sessions. PROMs of sleep (η2 = 0.033) and depression (η2 = 0.015) improved over time for participants in ReSET compared to usual care. Those randomized to ReSET also showed improved rest-activity rhythms relative to usual care, including mesor (η2 = 0.044), amplitude (η2 = 0.087), and R-squared (η2 = 0.073) actigraphy indices.

CONCLUSION

ReSET demonstrated feasibility, acceptability, and preliminary promise for intervention efficacy.