Contemporary Clinical Trials Communications (Apr 2023)

Protocol of a dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers

  • Youngmee Kim,
  • Amanda Ting,
  • Jennifer L. Steel,
  • Thomas C. Tsai

Journal volume & issue
Vol. 32
p. 101064

Abstract

Read online

Background: Sleep disturbance is common and problematic among both patients with cancer and their sleep partner caregivers. Although 70% of the general adult population sleep in the same bed with a significant other, as do adult cancer patients and their spousal/partner caregivers, and one's sleep affect the partner's sleep, existing psychobehavioral interventions have targeted patients' and caregivers' sleep problems independently. Methods: We developed a new sleep intervention, My Sleep Our Sleep (MSOS), for both adult patients with cancer and their sleep-partner caregivers together. This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the MSOS intervention, which is a dyadic intervention designed to reduce sleep disturbance and improving sleep quality of both adult cancer patients and their sleep-partner caregivers (dyads). The intervention will be delivered weekly for 4 weeks. Questionnaire and daily sleep logs will be collected at baseline (T1) and one-week after conclusion of the intervention (T2). Satisfaction with the intervention will be assessed weekly for 4 weeks. Results: We estimate 43 dyads be enrolled (43 patients and 43 sleep-partner caregivers). We expect >75% of eligible and screened dyads will enroll within the enrollment period, >80% of enrolled dyads will complete the intervention, and >80% of participants will report satisfaction across all acceptability measures. We also expect MSOS will reveal a small-to-medium effect on sleep efficiency (primary outcome), overall sleep disturbance, subjective sleep quality, and insomnia severity (secondary outcomes). Conclusions: Results will inform the feasibility and acceptability of conducting a dyadic sleep intervention, and provide preliminary efficacy data to guide further refinement of the intervention content and procedure for adult patients with cancer and their sleep-partner caregivers. Trial registration: NCT04712604 Clinicaltrials.gov

Keywords