Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol

Rina S Fox, Julia S Gaumond, Phyllis C Zee, Karen Kaiser, Edward J Tanner, Sonia Ancoli-Israel, Juned Siddique, Frank J Penedo, Lisa M Wu, Kathryn J Reid, Sairam Parthasarathy, Terry A Badger, Christine Rini, Jason C Ong, Rina S Fox, Julia S Gaumond, Phyllis C Zee, Karen Kaiser, Edward J Tanner, Sonia Ancoli-Israel, Juned Siddique, Frank J Penedo, Lisa M Wu, Kathryn J Reid, Sairam Parthasarathy, Terry A Badger, Christine Rini, Jason C Ong

Abstract

Sleep difficulties, particularly symptoms of insomnia and circadian disruption, are among the primary complaints of gynecologic cancer survivors before, during, and after treatment. Moreover, difficulty sleeping has been linked to poorer health-related quality of life and elevated symptom burden in this population. Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent to these treatments, likely because these interventions require labor-intensive behavior and lifestyle changes. Therefore, there is a need for more effective and acceptable approaches to diminish sleep disturbance among cancer survivors. This manuscript describes the methodology of a two-part study guided by the Multiphase Optimization Strategy (MOST) framework to identify a streamlined behavioral sleep intervention for gynecologic cancer survivors. Three candidate intervention components previously shown to decrease sleep disturbance will be evaluated, including sleep restriction, stimulus control, and systematic bright light exposure. Participants will be adult women with a history of non-metastatic gynecologic cancer who have completed primary treatment and who report current poor sleep quality. Fifteen participants will be recruited for Part 1 of the study, which will utilize qualitative methods to identify barriers to and facilitators of intervention adherence. Results will inform changes to the delivery of the candidate intervention components to promote adherence in Part 2, where 80 participants will be recruited and randomized to one of eight conditions reflecting every possible combination of the three candidate intervention components in a full factorial design. Participants will complete assessments at baseline, post-intervention, and 3-months post-intervention. Part 2 results will identify the combination of candidate intervention components that yields the most efficacious yet efficient 6-week intervention for diminishing sleep disturbance. This is the first known study to apply the MOST framework to optimize a behavioral sleep intervention and will yield a resource-efficient treatment to diminish sleep disturbance, improve health-related quality of life, and decrease symptom burden among gynecologic cancer survivors. ClinicalTrials.gov Identifier: NCT05044975.

Keywords: behavioral sleep intervention; cancer survivorship; gynecologic cancer; optimization; sleep disturbance.

Conflict of interest statement

SP is a consultant for Jazz Pharmaceuticals, Inc., receives royalty from UpToDate, Inc., and has a patent that was licensed by SaiOx, Inc. (US20160213879A1). SP reports receiving grants to institution from the following entities: Sergey Brin Family Foundation (Verily Life Sciences, Inc.), Philips-Respironics, Inc., WHOOP, Inc., Sommetrics, Inc., and Regeneron, Inc. These conflicts are unrelated to this manuscript. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Fox, Gaumond, Zee, Kaiser, Tanner, Ancoli-Israel, Siddique, Penedo, Wu, Reid, Parthasarathy, Badger, Rini and Ong.

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