Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors (SIESTA-P)
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Details and patient eligibility
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Traci Bethea
Data sourced from clinicaltrials.gov
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