Dataset Information

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

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.

SUBMITTER: Kim Y

PROVIDER: S-EPMC9871738 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Kim Youngmee Y Ting Amanda A Steel Jennifer L JL Tsai Thomas C TC

Contemporary clinical trials communications 20230116

<h4>Background</h4>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.<h4>Methods</h4>We developed a new sleep intervention, My ...[more]

PMID: 36704757

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Project description:BackgroundPatients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients' and their caregivers' health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads.ObjectiveThe purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic.MethodsA mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects.ResultsThis study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024.ConclusionsDeveloping a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers.Trial registrationClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203.International registered report identifier (irrid)PRR1-10.2196/48499.

Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

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