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Can an online sleep program help black prostate cancer survivors get better rest?

NCT ID NCT07128927

Symptom relief Sponsor: Georgetown University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing whether a web-based insomnia treatment called SHUTi can help Black/African American prostate cancer survivors sleep better. Forty participants will be randomly assigned to either the SHUTi program or an educational website. The study will check if the program is easy to use and acceptable, and whether it improves sleep and well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sleep Healthy Using the Internet (SHUTi) - a web-based cognitive behavioral therapy for insomnia
What this could lead to
If successful, this could provide an accessible, non-drug treatment option for insomnia in Black prostate cancer survivors, improving their sleep and quality of life.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. The web-based approach may not work for all individuals, and the study does not test long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Georgetown Lombardi Comprehensive Cancer Center

    RECRUITING

    Washington D.C., District of Columbia, 20003, United States

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