Web-based insomnia treatment for Black prostate cancer survivors
Official title: Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
Run by Georgetown University · NCT07128927 · Data updated 2026-11-12
This project will test whether an online cognitive behavioral therapy program called SHUTi helps Black prostate cancer survivors with insomnia compared with an online educational website.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | Georgetown University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07128927 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Black/African American men aged 21 or older with invasive prostate cancer diagnosed within the past five years, clinically relevant insomnia (ISI ≥10), English literate, and with internet access or willingness to attend weekly study visits are ideal candidates.
✕Probably not a fit
Patients working night shifts or safety-sensitive jobs, those with severe psychiatric disorders or recent seizures, or those unable to consent are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized trial will enroll Black/African American men treated for invasive prostate cancer within the past five years who have clinically relevant insomnia (ISI ≥10). Participants are randomized to SHUTi, a six-lesson web-delivered cognitive behavioral therapy for insomnia, or to an online educational website; participants without reliable internet can attend weekly study appointments and complete weekly phone calls. The study will measure feasibility and acceptability and compare changes in insomnia severity and other patient-reported outcomes such as mood, fatigue, and cognitive function. Results will show whether SHUTi improves sleep and broader well-being compared with an educational resource in this population.
Why it matters
Potential benefit: If successful, SHUTi could improve sleep and related symptoms (mood, fatigue, cognition) and increase access to effective insomnia treatment for Black prostate cancer survivors.
How similar studies have gone: Web-based CBT-I programs, including SHUTi, have demonstrated results similar to in-person CBT-I in cancer and general populations, but few trials have specifically tested this approach in Black prostate cancer survivors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Study coordinator: Traci Bethea
- Email: siestap@georgetown.edu
- Phone: 202-687-5367
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.