NCT07128927 · Georgetown University
Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
(SIESTA-P)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Sleep Healthy Using the Internet (SHUTi)
Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia
BEHAVIORAL
Patient education
Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.
Primary outcome measures
Feasibility of study protocol
Time frame: 10-12 weeks
Assessed via: * the percentage of survivors screened as eligible who consent to participate, * the percentage of actual vs. planned participants enrolled, and * the percentage of enrolled participants complete follow-up data collection
Acceptability of intervention
Time frame: 10-12 weeks
Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations