Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep Healthy Using the Internet (SHUTi)
BehavioralWeb-based, self-administered, and interactive cognitive behavioral therapy for insomnia
Patient education
BehavioralWebsite that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sleep Healthy Using the Internet (SHUTi)Experimental treatment 1 intervention
Group B: Patient educationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
10-12 weeks2
Acceptability of intervention
Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)
Time frame
10-12 weeksSecondary outcomes
1
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
Time frame
10-12 weeksOther outcomes
1
Impact on non-insomnia patient-reported outcomes
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): * Functional Assessment of Cancer Therapy - Prostate (range: 0-156, higher score = better quality of life, score below baseline median = 1 PRO) * Male Depression Risk Scale short form (range: 0-154, higher score = greater symptoms of depression, score above baseline median = 1 PRO) * 18-item Memorial Anxiety Scale for Prostate Cancer (range: 0-54, higher score = greater anxiety symptoms, score above baseline median = 1 PRO) * Functional Assessment of Cancer Therapy - Cognitive Function - Perceived Cognitive Impairments (range: 0-72, higher score = better cognitive function, score below baseline median = 1 PRO) * Hot Flash Related Daily Interference Scale (range: 0-100, higher score = more interference, score above baseline median = 1 PRO)
Time frame
10-12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov