RCT of brief behavioral therapy (BBT-CI) for cancer-related insomnia and circadian rhythm during chemotherapy in a community oncology setting (NCORP).

Abstract

10094 Background: Insomnia is experienced by up to 80% of cancer patients, and it frequently co-occurs with circadian rhythm disruption. The relationship is reciprocal in that disruption in circadian rhythm can cause or result from insomnia and vice versa. There are no effective brief behavioral interventions that can be delivered directly in infusion centers. We aimed to evaluate the efficacy of a novel intervention, BBT-CI, for improving sleep and circadian rhythm disruption in BC patients undergoing chemotherapy. Methods: In our phase II, two-arm, randomized clinical trial, 71 BC patients (mean age = 52.5) who reported moderate insomnia were randomized to: 1) BBT-CI or 2) a healthy eating behavioral control (HEAL). BBT-CI and HEAL were delivered over 6 weeks (2 face-to-face sessions + 4 phone calls) at 5 NCI-funded NCORP clinics by trained assistants. Sleep disruption was measured with the Insomnia Severity Index (ISI) and circadian rhythm with the Actiwatch-64 (Mesor, Amplitude, and Acrophase for 12- and 24-hour cycles). Participants completed the ISI at baseline and post-intervention and wore the Actiwatch for 7 days prior to each visit. Results: The study showed excellent feasibility and acceptability of BBT-CI as reflected by a recruitment rate of over 75% and an intervention adherence of 74%, with 75% of intervention components successfully delivered by trained community staff. ANCOVA results indicate that patients who received BBT-CI exhibited improvements in insomnia compared to HEAL at post-intervention (p = .049) and at 1-month follow-up (p = .002). Furthermore, results reveal a significant treatment effect in circadian rhythm at post-intervention for 24-hour amplitude (p = .009) and 12-hour Acrophase (p = .012) as well as a trend for Mesor in favor of BBT-CI (p = .10). Conclusions: BBT-CI demonstrated greater improvements in insomnia and circadian rhythm than HEAL. In addition, this novel intervention has shown efficacy in community oncology clinics. BBT-CI has the potential of changing clinical practice as it reduces patients’ psychophysiological symptoms and burden due to its behavioral design and capacity to be delivered directly in infusion centers. Clinical trial information: NCT02002533.