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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT07128927
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sleep Healthy Using the Internet (SHUTi) — BEHAVIORAL
    Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia
  • Patient education — BEHAVIORAL
    Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Feasibility of study protocol [ Time Frame: 10-12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20003
Traci Bethea
[email protected]
202-687-5367
Traci Bethea (PRINCIPAL_INVESTIGATOR)
Paul Leger (SUB_INVESTIGATOR)

Find similar trials in Washington D.C., DC

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By specialty
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Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DC

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