Clinical trial · Interventional
Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient education | Behavioral | — | UNRESOLVED |
| Sleep Healthy Using the Internet (SHUTi) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sleep Healthy Using the Internet (SHUTi)
- description
- 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.
- interventionNames
- Behavioral: Sleep Healthy Using the Internet (SHUTi)
- type
- PLACEBO_COMPARATOR
- label
- Patient education
- description
- Static information about insomnia provided on a patient education website
- interventionNames
- Behavioral: Patient education
Primary outcomes (2)
- measure
- Feasibility of study protocol
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDBai 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
- BACKGROUNDGonzalez 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
- BACKGROUNDLeger 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
- BACKGROUNDRitterband 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