Web-based insomnia treatment for Black prostate cancer survivors
Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | Georgetown University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07128927 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.