Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All participants will complete study visits and data collection, including sleep diaries and questionnaires, at baseline and post-intervention (10-12 weeks later)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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
Study sites (1)
DC
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., DC 20003Traci Bethea · Study contact · 202-687-5367 · siestap@georgetown.eduTraci Bethea · Principal investigatorPaul Leger · Sub-investigatorMore trials in Washington D.C.