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

NCT07128927 | Recruiting

• 1 other identifier: STUDY00007350
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia

Keywords

insomnia; Sleep Healthy Using the Internet (SHUTi); prostate cancer survivorship; cognitive behavioral therapy for insomnia

Outcome Measures

Primary Outcomes (2)

• Feasibility of study protocol

  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

  10-12 weeks

• Acceptability of intervention

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

  10-12 weeks

Secondary Outcomes (1)

• Efficacy of intervention

  10-12 weeks

Other Outcomes (1)

• Impact on non-insomnia patient-reported outcomes

  10-12 weeks

Study Arms (2)

Sleep Healthy Using the Internet (SHUTi)

EXPERIMENTAL

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.

Behavioral: Sleep Healthy Using the Internet (SHUTi)

Patient education

PLACEBO COMPARATOR

Static information about insomnia provided on a patient education website

Behavioral: Patient education

Interventions

Sleep Healthy Using the Internet (SHUTi) BEHAVIORAL

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

Also known as: Cognitive behavioral therapy for insomnia, CBT-i

Sleep Healthy Using the Internet (SHUTi)

Patient education BEHAVIORAL

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

Also known as: Sleep hygiene

Patient education

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

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

RECRUITING

Related Publications (4)

• Bai P. Application and Mechanisms of Internet-Based Cognitive Behavioral Therapy (iCBT) in Improving Psychological State in Cancer Patients. J Cancer. 2023 Jul 3;14(11):1981-2000. doi: 10.7150/jca.82632. eCollection 2023.

  PMID: 37497400 BACKGROUND

• Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.

  PMID: 29072790 BACKGROUND

• Leger P, Frencher S Jr, Nauseef JT, Jones B, Bilen MA, Brown A Jr, Ullah A, McDevitt S, Tsao CK. A multi-perspective study assessing Black and African American participation barriers in prostate cancer clinical trials. Future Oncol. 2025 Apr;21(8):967-973. doi: 10.1080/14796694.2025.2467519. Epub 2025 Feb 24.

  PMID: 39992723 BACKGROUND

• Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.

  PMID: 19581560 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Patient Education as Topic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Traci Bethea

CONTACT

202-687-5367; siestap@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)