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.
Introduction Sleep disturbance is one of the primary symptoms reported by cancer survivors before, during, and after treatment. To better understand trajectories of sleep disturbance over the course of chemotherapy, we evaluated patient-reported symptoms among adults being treated for lymphoma. Methods Participants were 18-74 years old, English-speaking, and scheduled to be treated with a full course of anthracycline-based chemotherapy. Among other assessments, participants completed a battery of patient-reported outcome measures prior to the first cycle of chemotherapy (T1) and on the final days of the second (T2) and fourth (T3) cycles. Sleep symptoms were assessed with the Insomnia Severity Index (ISI), PROMIS Sleep Disturbance (PROMIS-SD), and PROMIS Sleep-Related Impairment (PROMIS-SRI) measures. Given the small sample size, descriptives and effect sizes were calculated rather than conducting inferential analyses. Results Participants were 9 adults with Hodgkin’s (n=5) or Non-Hodgkin’s (n=4) lymphoma, mean age 41 years (SD=13.9), mostly male (89%), White (78%), and non-Hispanic (89%). The majority had higher scores on the ISI (85.7%), PROMIS-SD (71.4%), and PROMIS-SRI (71.4%) at T2 than T1, demonstrating more sleep disturbance mid-chemotherapy than prior to chemotherapy. Conversely, the majority had lower scores at T3 than T2 (ISI: 80.0%, PROMIS-SD: 80.0%, PROMIS-SRI: 100.0%), demonstrating less sleep disturbance at late-chemotherapy than mid-chemotherapy. For most participants scores remained higher at T3 than T1 (all 3 measures: 75.0%), indicating more sleep disturbance at late-chemotherapy than pre-chemotherapy. Averaged across participants, differences in scores from T1 to T2 were small-to-medium (ISI: Hedges’ g=0.42, PROMIS-SD: g=0.44, PROMIS-SRI: g=0.62), from T1 to T3 were small (ISI: g=0.26, PROMIS-SD: g=0.26, PROMIS-SRI: g=0.23), and from T2 to T3 were medium-to-large (ISI: g=0.98, PROMIS-SD: g=0.73, PROMIS-SRI: g=0.53). Conclusion Patient-reported sleep symptoms worsened over the first two cycles of anthracycline-based chemotherapy. Symptoms improved over the subsequent two cycles; however, for most participants they remained worse than baseline levels. Pending replication in a larger sample, intervening before initiating chemotherapy or during the early cycles thereof may be beneficial to diminish sleep disturbance among patients with lymphoma. Support (if any) The project described was supported by the Robert H. Lurie Comprehensive Cancer Center. RSF was supported by NCI grant #K08CA247973. EH was supported by NHLBI grant #K01HL152009.
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