TY - JOUR
T1 - Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors
T2 - Study Design and Protocol
AU - Fox, Rina S.
AU - Gaumond, Julia S.
AU - Zee, Phyllis C.
AU - Kaiser, Karen
AU - Tanner, Edward J.
AU - Ancoli-Israel, Sonia
AU - Siddique, Juned
AU - Penedo, Frank J.
AU - Wu, Lisa M.
AU - Reid, Kathryn J.
AU - Parthasarathy, Sairam
AU - Badger, Terry A.
AU - Rini, Christine
AU - Ong, Jason C.
N1 - Funding Information: This work was supported by the National Cancer Institute under grant #K08CA247973 (PI: Fox) and the University of Arizona College of Nursing. LW’s effort was supported by the European Union’s Horizon 2020 Research and Innovation Programme under the Marie Sklodowska–Curie grant agreement no. 754513 and the Aarhus University Research Foundation. Funding Information: 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. Publisher Copyright: Copyright © 2022 Fox, Gaumond, Zee, Kaiser, Tanner, Ancoli-Israel, Siddique, Penedo, Wu, Reid, Parthasarathy, Badger, Rini and Ong.
PY - 2022/3/4
Y1 - 2022/3/4
N2 - 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.
AB - 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.
KW - behavioral sleep intervention
KW - cancer survivorship
KW - gynecologic cancer
KW - optimization
KW - sleep disturbance
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U2 - 10.3389/fnins.2022.818718
DO - 10.3389/fnins.2022.818718
M3 - Article
SN - 1662-4548
VL - 16
JO - Frontiers in Neuroscience
JF - Frontiers in Neuroscience
M1 - 818718
ER -