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
Traci Bethea
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07128927
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.
Interested in participating?
Request Info21 year and older
Male
Interventional
Not applicable
Washington D.C., District of Columbia, 20003, United States
Location status: Recruiting
Paul Leger
SUB_INVESTIGATOR
Traci Bethea
CONTACT
Traci Bethea
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia
Other names: Cognitive behavioral therapy for insomnia, CBT-i
Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.
Other names: Sleep hygiene
Time frame: 10-12 weeks
Assessed via:
Time frame: 10-12 weeks
Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)
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
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):
Contact information is provided by the study sponsor or research team.
Georgetown University
Other
Acronym: SIESTA-P
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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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