Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance

Not Applicable

Completed

Interventions: Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference

Brief Summary: The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference	Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference

Primary Outcome Measures

Name	Time	Method
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances	Baseline	The study will be deemed acceptable if ≥ 50% of eligible cancer survivors who are approached agree to participate. Recruitment rate will be measured by percentage of patients enrolled.
Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances	Approximately 6 weeks after first intervention session	The study will be deemed acceptable if \> 50% of intervention group participants report that, on average, they agree with positive statements about the intervention (i.e., report an average score of \>3 on a scale of 0 to 4).
Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances	approximately 6 weeks after first intervention session	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of New Intervention Using PSQI Scoring	Baseline and approximately 6 weeks after first intervention session	Pittsburgh Sleep Quality Index (PSQI) Scoring: Duration of Sleep, Sleep Disturbance, Sleep Latency, Days of Disfunction due to Sleepiness, Sleep Efficiency, Overall Sleep Quality, and Meds Needed to Sleep Response Scale 0 (better) 3 (worse). Total Minimum Score 0 (Better), Total Maximum Score 21 (Worse) ≤ 5 = Good Sleep Quality \>5 = Poor Sleep Quality
Efficacy of New Intervention Using ISI Scoring	Baseline and approximately 6 weeks after first intervention session	Insomnia Severity Index (ISI) Scoring: Sleep Quality, Symptom Severity, Sleep Patterns, Daily Functioning, Insomnia Noticeable to Others, Level of Distress Caused by Insomnia Response Scale 0 (better) 4 (worse) Total Minimum Score 0 (Better) Total Maximum Score 28 (Worse) 0-7: No Clinically Significant Insomnia 8-14: Subthreshold Insomnia 15-21: Clinical Insomnia 22-28: Severe Clinical Insomnia

Locations (2): H Lee Moffitt Cancer and Research Institute
🇺🇸
Tampa, Florida, United States
Ponce Health Services University
🇵🇷
Ponce, Puerto Rico