The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: December 24, 2021
- Behavioral: New Intervention for Cancer-Related Sleep Disturbance
- Modality of this intervention will be determined in Arm 1
Arms, Groups and Cohorts
- No Intervention: Pre-Intervention Qualitative Interviews
- Qualitative interviews will be conducted with breast cancer survivors, survivors’ caregivers, cancer support group leaders and clinicians regarding sleep disturbance in breast cancer survivors and preferences for an intervention for sleep disturbance.
- Experimental: Efficacy of new intervention
- Behavioral: New intervention for cancer-related sleep disturbances. The modality of this intervention will be determined after pre-intervention qualitative interviews are completed.
Clinical Trial Outcome Measures
- Acceptability of New Intervention for Cancer-Related Sleep Disturbances
- Time Frame: Up to 12 months
- The study will be deemed acceptable if ≥ 50% of eligible cancer survivors who are approached agree to participate and > 50% of intervention group participants report that, on average, they are at least “mostly satisfied” with the intervention (i.e., report an average score of ≥ 3 on a scale of 1 to 4).
- Feasibility of New Intervention for Cancer-Related Sleep Disturbances
- Time Frame: Up to 12 months
- The study will be deemed feasible if ≥ 75% of the intervention group participants attend at least half of the educational components of the intervention. This will be operationalized as having attended at least half of the sessions.
- Efficacy of New Intervention
- Time Frame: Up to 18 months
- Efficacy of the newly created intervention will be assessed using (a) Scores on the Pittsburgh Sleep Quality Index, which consists of 19 individual items creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the 7 component scores, producing a score ranging from 0-21, where lower scores denote a healthier sleep quality. (b) the Insomnia Severity Index, which has 7 questions on a 0-4 scale which is totaled producing a score ranging from 0-28, where lower score denotes no clinically significant insomnia.
Participating in This Clinical Trial
- Located in the Southern Puerto Rico area – Able to speak and read Spanish – Have no documented or observable disabilities that would interfere with study participation – Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation) – Has clinically significant sleep disturbance (i.e., >/= 8 on the Insomnia Severity Index) – Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy – Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software Exclusion Criteria:
- Not able to read and speak Spanish
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Provider of Information About this Clinical Study
- Overall Official(s)
- Brian D Gonzalez, PhD, Principal Investigator, H. Lee Moffitt Cancer and Research Institute
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