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.
Highlights
Sleep Disturbance in Cancer SurvivorshipSleep difficulties, symptoms of insomnia and circadian disruption, are common among gynecologic cancer survivors (Westin et al, 2016; Campbell et al, 2019; Palagini et al, 2021), with recent research demonstrating an estimated prevalence greater than 80% (Pozzar et al, 2021)
This paper describes the procedures and methodology of a twopart study guided by the Multiphase Optimization Strategy (MOST) framework
By leveraging the MOST framework, Part 2 of this study will efficiently test the efficacy of three candidate intervention components independently and in combination to identify a resource-efficient, maximally effective, evidence-based behavioral sleep intervention for gynecologic cancer survivors that consists of exclusively active components
Summary
Sleep Disturbance in Cancer SurvivorshipSleep difficulties, symptoms of insomnia and circadian disruption, are common among gynecologic cancer survivors (Westin et al, 2016; Campbell et al, 2019; Palagini et al, 2021), with recent research demonstrating an estimated prevalence greater than 80% (Pozzar et al, 2021). A recent metaanalysis evaluating the efficacy of CBT-I in cancer survivors found that the intervention improved multiple sleep outcomes, including sleep efficiency, sleep onset latency, wake after sleep onset, and insomnia symptom severity (Johnson et al, 2016). CBT-I can be highly efficacious, up to 50% of cancer survivors do not adhere to the treatment as it is currently packaged, and do not benefit maximally from it (Matthews et al, 2012, 2013; McChargue et al, 2012; Garland et al, 2014) This may be because the intervention requires patients to make multiple, simultaneous, and often intrusive behavioral and lifestyle changes (Agnew et al, 2021). A less burdensome alternative is systematic bright light exposure, which has recently been explored as another strategy for improving sleep disturbance in cancer survivors (Wu et al, 2018, 2021; Fox et al, 2021). Effects are generally not as strong as they are for CBT-I, with research far limited to small pilot studies where the mechanisms underlying the effects of bright light have not been well explored
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
