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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Georgetown Lombardi Comprehensive Cancer Center
RECRUITING
Washington D.c.
Contact Information
Primary
Traci Bethea
siestap@georgetown.edu
202-687-5367
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Placebo_comparator: Patient education
Static information about insomnia provided on a patient education website
Related Therapeutic Areas
Sponsors
Leads: Georgetown University

This content was sourced from clinicaltrials.gov