N/A
Completed N=30
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
Source: ClinicalTrials.gov NCT04101526 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances — 30 Participants
Summary
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances |
30 | — |
| PRIMARY Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances |
3.56 | — |
| PRIMARY Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances |
15 | — |
| SECONDARY Efficacy of New Intervention Using PSQI Scoring |
11.60; 11.57; 7.40; 11.77 | — |
| SECONDARY Efficacy of New Intervention Using ISI Scoring |
18.87; 17.20; 7.80; 13.33 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04101526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.