Brief Behavioral Intervention for Insomnia During Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 139
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index (ISI)
Study Overview
Brief Summary
PRIMARY OBJECTIVE(S):
To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.
SECONDARY OBJECTIVE(S):
- To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
- To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Insomnia Severity Index (ISI)
Time Frame: 12 months
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
Secondary Outcomes
- Brief Fatigue Inventory (BFI)(12 months)
- Comprehensive Trail Making Test (CTMT)(At baseline, post intervention, 6 months and 12 months)
- Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall(At baseline, post intervention, 6 months and 12 months)
- Controlled Oral Word Association Test (COWAT)(At baseline, post intervention, 6 months and 12 months)
- Clinical Assessment of Depression (CAD)(12 months)
- Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory(At baseline, post intervention, 6 months and 12 months)
- Mobile Cognitive Assessment Battery (MCAB)(At baseline, post intervention, 6 months and 12 months)
Investigators
Oxana Palesh
Oxana Palesh PhD, MPH
Stanford University