The Better Sleep for Supporters With Insomnia Study — BeSSI  

Cancer Clinical Trial

Official title: Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers

Status Completed

Clinical Trial Summary

This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.

Clinical Trial Description

Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, and/or emotional support for a loved one with cancer endorse clinically significant sleep disturbance. Understanding caregivers' psychosocial risk factors and needs, and the extent to which these are unique to the cancer caregiving context, will ensure appropriate and effective interventions for cancer caregivers with insomnia.

Existing psychosocial services for caregivers are primarily delivered in-person. Although such interventions are effective, they suffer from low enrollment, high dropout, and limited reach to caregivers who already have inadequate healthcare access, like caregivers from lower SES or those in rural areas. Digital health interventions can lower barriers to entry to supportive care for caregivers as they are conveniently accessible anywhere and anytime from an Internet-enabled device. Sleep Healthy Using the Internet (SHUTi) is a NCI-designated research-tested intervention that delivers cognitive-behavioral therapy for insomnia (CBT-I) and holds significant potential to accessibly treat insomnia for cancer caregivers. Most digital health interventions tested among caregivers, however, have been developed de novo for specific caregiving contexts. The implicit assumption underlying highly tailored interventions for caregivers is that caregivers have different deficits, risk factors, and needs from non-caregivers. This assumption has not often been tested, and therefore the extent to which caregivers want and need tailoring for digital health interventions is not known. This study is therefore designed to provide the data necessary to ensure the highest quality, impact, and efficiency from existing evidence-based digital health interventions to meet pressing psychosocial needs among cancer caregivers. Specifically, this study will directly inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers.

The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence. There is no content that is specifically about cancer or caregiving.

Caregivers participating in this study will complete a baseline assessment (questionnaires and 2 weeks of daily sleep diaries), and then will receive complementary and voluntary access to SHUTi. Participants who choose to complete 1 or more SHUTi Cores will complete a follow-up assessment of questionnaires and 2 weeks of sleep diaries; participants who choose not to complete any SHUTi cores will be asked to provide brief feedback regarding their reasons/barriers. ;

Related Conditions & MeSH terms

• Cancer
• Family Caregivers
• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT04661306
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Completion date: January 31, 2022