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

doi:10.1016/j.conctc.2023.101064

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

Contemp Clin Trials Commun. 2023 Jan 16:32:101064. doi: 10.1016/j.conctc.2023.101064. eCollection 2023 Apr.

Authors

Youngmee Kim¹, Amanda Ting², Jennifer L Steel³, Thomas C Tsai¹

Affiliations

¹ Department of Psychology, University of Miami, Coral Gables, FL, USA.
² Department of Psychology, Palo Alto VA, Palo Alto, CA, USA.
³ Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA.

Abstract

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: Adult cancer; Patient-caregiver dyad; Sleep disturbance; Sleep intervention protocol.

Associated data

ClinicalTrials.gov/NCT04712604