[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07128927":3,"trial-entities:NCT07128927":118,"trial-summary:NCT07128927":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":53,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":14,"eligibility_criteria":60,"std_ages":76,"locations":79,"central_contacts":100,"overall_officials":102,"references":103,"see_also_links":117},"NCT07128927","STUDY00007350","Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors","RECRUITING","2026-09-01","2025-12","2025-12-05","2025-12-01","Georgetown University","OTHER",false,"This pilot study will recruit Black\u002FAfrican 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.","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\u002Fethnic 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.\n\nCognitive 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.\n\nThis 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).",[18],"Insomnia",[20,21,22,23],"insomnia","Sleep Healthy Using the Internet (SHUTi)","prostate cancer survivorship","cognitive behavioral therapy for insomnia","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32,39],{"type":33,"name":21,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia",[21],[37,38],"Cognitive behavioral therapy for insomnia","CBT-i",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Patient education","Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.",[40],[44],"Sleep hygiene",[46,50],{"measure":47,"description":48,"timeFrame":49},"Feasibility of study protocol","Assessed via:\n\n* the percentage of survivors screened as eligible who consent to participate,\n* the percentage of actual vs. planned participants enrolled, and\n* the percentage of enrolled participants complete follow-up data collection","10-12 weeks",{"measure":51,"description":52,"timeFrame":49},"Acceptability of intervention","Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)",[54],{"measure":55,"description":56,"timeFrame":49},"Efficacy of intervention","Assessed via change in the Insomnia Severity Index score (range: 0-28, higher score = more insomnia symptoms) from baseline to post-intervention","MALE","21 Years",null,{"inclusion":61,"exclusion":69,"raw_text":75},[62,63,64,65,66,67,68],"Age ≥21 years","Self-identifies as Black\u002FAfrican 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",[70,71,72,73,74],"Employed in an occupation where sleep restriction could be a harm to themselves or others","Actively employed in shift work","Diagnosed with a severe\u002Fmajor psychiatric disorder","Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure","Unable to consent","Inclusion Criteria:\n\n* Age ≥21 years\n* Self-identifies as Black\u002FAfrican American\n* Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years\n* Has not received surgery, chemotherapy, or radiation within the previous 3 months\n* 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\n* Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity Index)\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Employed in an occupation where sleep restriction could be a harm to themselves or others\n* Actively employed in shift work\n* Diagnosed with a severe\u002Fmajor psychiatric disorder\n* Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure\n* Unable to consent",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":97},"Georgetown Lombardi Comprehensive Cancer Center","Washington D.C.","District of Columbia","20003","United States",[87,92,94],{"name":88,"role":89,"phone":90,"email":91},"Traci Bethea","CONTACT","202-687-5367","siestap@georgetown.edu",{"name":88,"role":93},"PRINCIPAL_INVESTIGATOR",{"name":95,"role":96},"Paul Leger","SUB_INVESTIGATOR",{"lat":98,"lon":99},38.89511,-77.03637,[101],{"name":88,"role":89,"phone":90,"email":91},[],[104,108,111,114],{"pmid":105,"type":106,"citation":107},"37497400","BACKGROUND","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\u002Fjca.82632. eCollection 2023.",{"pmid":109,"type":106,"citation":110},"29072790","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\u002Fcncr.31024. Epub 2017 Oct 26.",{"pmid":112,"type":106,"citation":113},"39992723","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\u002F14796694.2025.2467519. Epub 2025 Feb 24.",{"pmid":115,"type":106,"citation":116},"19581560","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\u002Farchgenpsychiatry.2009.66.",[],{"nct_id":4,"conditions":119,"biomarkers":121},[18,120],"Prostate Carcinoma",[],{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study that will randomize 40 participants to one of two treatments: SHUTi or an educational website.","completed","Web-based Insomnia Treatment for Black\u002FAfrican American Prostate Cancer Survivors","This pilot study is looking at web-based treatments for insomnia in Black\u002FAfrican American men who have survived prostate cancer. It compares two interventions: \"Sleep Healthy Using the Internet (SHUTi),\" which is an online cognitive behavioral therapy (CBT) for insomnia, and an educational website about insomnia. The study aims to see if SHUTi is practical to use and acceptable to participants, and how it compares to the educational website in improving sleep and overall well-being. You may be able to join if you are a Black\u002FAfrican American man, at least 21 years old, diagnosed with prostate cancer within the last 5 years, and have not had recent surgery, chemotherapy, or radiation. You also need reliable internet access or be willing to attend weekly study appointments. The study plans to enroll 40 participants, but its current recruitment status is unclear.","The feasibility and acceptability of the interventions will be measured at 10-12 weeks.",138,"You would either need a smartphone, tablet, or computer with reliable internet access, or be willing to attend a weekly study appointment and complete a weekly phone call.","Not stated in the trial record.",[21],"v2"]