JMIR Publications

ABSTRACT

Background:

Background:

Cancer survivors are at an increased risk for chronic insomnia, even years after treatment completion. Connected to a variety of long-term health consequences, access to insomnia treatment is critically important for the cancer survivor population. Cognitive Behavioral Therapy for Insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and treatment regimens that are burdensome to patients. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online.

Objective:

Objective:

This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve insomnia symptoms and mood in cancer survivors compared to a control condition. The secondary aims will i) explore participant and program adherence factors associated with clinically significant response, ii) evaluate acceptability of the control intervention, iii) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to the STEP-1 intervention, and iv) describe participants’ satisfaction with STEP-1 and suggestions for improvement.

Methods:

Methods:

This 2-arm randomized controlled trial will enroll 70 off-treatment cancer survivors aged 40-89 with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or the control condition (relaxation education); interventions are delivered in 1-on-1, synchronous virtual sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. Together with the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides participants with information on how to independently access an application and online video resources for mind- and body-oriented relaxation exercises. The Insomnia Severity Index (ISI) is used to measure insomnia symptoms and the Profile of Mood States: Short Form (POMS-SF) is used to measure mood, at baseline and four- and eight-weeks post-intervention.

Results:

Results:

Enrollment began in February 2023, with 68 participants currently enrolled. Recruitment is anticipated to conclude in the summer of 2024. Primary endpoint is change in ISI score at 8 weeks post-intervention, and secondary endpoint is change in mood symptoms (POMS-SF) at 8 weeks. A repeated-measures analysis of variance will be used to determine if the STEP-1 intervention significantly reduces insomnia symptoms and improves mood symptoms compared to a control condition. Secondary aims will be analyzed using descriptive statistics (secondary aims ii, iii, iv), logistic regression (secondary aim i) and t-tests and Chi-square analyses (secondary aim ii).

Conclusions:

STEP-1 aims to provide cancer survivors access to effective behavioral insomnia treatment by testing a brief, low-intensity intervention that addresses their needs and interests and can be delivered to them wherever they have internet access. If found effective, this approach has the potential to greatly improve access to care for the growing population of survivors whose health and quality of life are affected by insomnia. This study will confirm the appropriateness of conducting a future effectiveness trial and inform its design. Clinical Trial: Sleep Treatment Education Program-1 (STEP-1) NCT05519982 https://www.clinicaltrials.gov/study/NCT05519982?intr=STEP-1&rank=1