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NCT Number: NCT07128927

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

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.

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown Lombardi Comprehensive Cancer Center

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

Location status: Recruiting

Location contact

Paul Leger

SUB_INVESTIGATOR

Traci Bethea

CONTACT

[email protected]

202-687-5367

Traci Bethea

PRINCIPAL_INVESTIGATOR

About this study

Insomnia is a risk factor for poor physical, cognitive, and psychosocial outcomes, including depression, anxiety, frailty, and diminished cognitive function, especially among cancer survivors. Although Cancer treatment, including androgen deprivation therapy, may increase insomnia symptoms and the prevalence of insomnia among prostate cancer survivors is estimated to be 25-39%. Prostate cancer has the highest incidence rate and second highest mortality rate among men in the U.S. with a highest burden of both incidence and mortality among Black men compared to men of other racial/ethnic groups. However, few studies have examined treatment of insomnia in this population. Insomnia is associated with greater symptom burden (i.e., multiple concurrent symptoms, such as depression, anxiety, fatigue, pain, cognition) among prostate cancer survivors, so treating insomnia may provide an opportunity to improve well-being in this population.

Cognitive Behavioral Therapy for Insomnia (CBT-I) has demonstrated substantial and persistent improvements in insomnia severity among cancer survivors such that the National Comprehensive Cancer Network (NCCN) recommends it "as the preferred treatment for insomnia." Trials to develop and test web-based and digital CBT-I interventions have shown non-inferiority to in-person administration by a trained therapist and increase availability of insomnia treatment to more patients. Recent NCCN guidelines note that improving sleep may provide additional benefits by resulting in less fatigue, better mood, better quality of life, and improved survival. However, to date, this accessible and interactive intervention has not been investigated among prostate cancer survivors.

This study uses the Sleep Healthy Using the Internet (SHUTi) program to provide CBT-I via the internet. SHUTi is self-administered and interactive with 6 weekly 45-60 minute sessions delivered over the course of 9 weeks. The program uses sleep diary data provided by each participant to tailor recommendations. Prostate cancer survivors participating in this pilot study will be randomized to receive access to SHUTi or to a patient education website. All participants will complete study visits and data collection, including sleep diaries and questionnaires, at baseline and post-intervention (10-12 weeks later).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Healthy Using The Internet (SHUTi)

Behavioral

Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia

Other names: Cognitive behavioral therapy for insomnia, CBT-i

Patient education

Behavioral

Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.

Other names: Sleep hygiene

Primary outcomes

  1. 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
  2. Acceptability of intervention

    Time frame: 10-12 weeks

    Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)

Secondary outcomes

  1. Efficacy of intervention

    Time frame: 10-12 weeks

    Assessed via change in the Insomnia Severity Index score (range: 0-28, higher score = more insomnia symptoms) from baseline to post-intervention

Other outcomes

  1. Impact on non-insomnia patient-reported outcomes

    Time frame: 10-12 weeks

    Assessed via change in total number of reported non-insomnia patient-reported symptoms from baseline to post-intervention (range: 0-5, higher number = greater change in symptoms):

    • Functional Assessment of Cancer Therapy - Prostate (range: 0-156, higher score = better quality of life, score below baseline median = 1 PRO)
    • Male Depression Risk Scale short form (range: 0-154, higher score = greater symptoms of depression, score above baseline median = 1 PRO)
    • 18-item Memorial Anxiety Scale for Prostate Cancer (range: 0-54, higher score = greater anxiety symptoms, score above baseline median = 1 PRO)
    • Functional Assessment of Cancer Therapy - Cognitive Function - Perceived Cognitive Impairments (range: 0-72, higher score = better cognitive function, score below baseline median = 1 PRO)
    • Hot Flash Related Daily Interference Scale (range: 0-100, higher score = more interference, score above baseline median = 1 PRO)

Study contacts

Contact information is provided by the study sponsor or research team.

Traci Bethea

CONTACT

[email protected]

202-687-5367

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Acronym: SIESTA-P

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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