Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-09-01

Brief Summary

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This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.

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Detailed Description

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Insomnia is a risk factor for poor physical, cognitive, and psychosocial outcomes, including depression, anxiety, frailty, and diminished cognitive function, especially among cancer survivors. Although Cancer treatment, including androgen deprivation therapy, may increase insomnia symptoms and the prevalence of insomnia among prostate cancer survivors is estimated to be 25-39%. Prostate cancer has the highest incidence rate and second highest mortality rate among men in the U.S. with a highest burden of both incidence and mortality among Black men compared to men of other racial/ethnic groups. However, few studies have examined treatment of insomnia in this population. Insomnia is associated with greater symptom burden (i.e., multiple concurrent symptoms, such as depression, anxiety, fatigue, pain, cognition) among prostate cancer survivors, so treating insomnia may provide an opportunity to improve well-being in this population.

Cognitive Behavioral Therapy for Insomnia (CBT-I) has demonstrated substantial and persistent improvements in insomnia severity among cancer survivors such that the National Comprehensive Cancer Network (NCCN) recommends it "as the preferred treatment for insomnia." Trials to develop and test web-based and digital CBT-I interventions have shown non-inferiority to in-person administration by a trained therapist and increase availability of insomnia treatment to more patients. Recent NCCN guidelines note that improving sleep may provide additional benefits by resulting in less fatigue, better mood, better quality of life, and improved survival. However, to date, this accessible and interactive intervention has not been investigated among prostate cancer survivors.

This study uses the Sleep Healthy Using the Internet (SHUTi) program to provide CBT-I via the internet. SHUTi is self-administered and interactive with 6 weekly 45-60 minute sessions delivered over the course of 9 weeks. The program uses sleep diary data provided by each participant to tailor recommendations. Prostate cancer survivors participating in this pilot study will be randomized to receive access to SHUTi or to a patient education website. All participants will complete study visits and data collection, including sleep diaries and questionnaires, at baseline and post-intervention (10-12 weeks later).

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sleep Healthy Using the Internet (SHUTi)

SHUTi provides 6 sessions of 45-60 minutes in length delivered over the course of 6-9 weeks. The program tailors recommendations based on sleep diary data provided by each participant.

Group Type EXPERIMENTAL

Sleep Healthy Using the Internet (SHUTi)

Intervention Type BEHAVIORAL

Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia

Patient education

Static information about insomnia provided on a patient education website

Group Type PLACEBO_COMPARATOR

Patient education

Intervention Type BEHAVIORAL

Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.

Interventions

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Sleep Healthy Using the Internet (SHUTi)

Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia

Intervention Type BEHAVIORAL

Patient education

Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive behavioral therapy for insomnia CBT-i Sleep hygiene

Eligibility Criteria

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Inclusion Criteria

* Age ≥21 years
* Self-identifies as Black/African American
* Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years
* Has not received surgery, chemotherapy, or radiation within the previous 3 months
* Has a smart phone, tablet, or computer with reliable internet access or willing to attend a weekly study appointment and to complete a weekly phone call
* Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity Index)
* Able to read and understand English

Exclusion Criteria

* Employed in an occupation where sleep restriction could be a harm to themselves or others
* Actively employed in shift work
* Diagnosed with a severe/major psychiatric disorder
* Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure
* Unable to consent

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No