Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
Recruiting · NCT07128927 · Interventional (participants receive a specific treatment) · Lead sponsor: Georgetown University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C., District of Columbia, United States