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

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

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

Conditions
-----------------
Sleep Disturbance

Intervention / Treatment
-----------------
* Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Intervention Qualitative Interviews<br>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: Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)<br>Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference | Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference<br>* Six sessions of Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference. Sessions address topics such as sleep education, sleep hygiene, sleep restriction, stimulus control, relapse prevention, and cognitive restructuring.<br>|
| No Intervention: Waitlist control group<br>No intervention until 6 weeks after the baseline assessment, at which point participants complete a follow-up assessment and then are offered the new CBT-I intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of New Intervention for Cancer-Related Sleep Disturbances | 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 agree with positive statements about the intervention (i.e., report an average score of ≥3 on a scale of 0 to 4). | approximately 6 weeks after first intervention session | 
| Feasibility of New Intervention for Cancer-Related Sleep Disturbances | 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. | approximately 6 weeks after first intervention session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of New Intervention | 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. Items are totaled to produce a score ranging from 0-28, where higher scores denote worse insomnia severity. | approximately 6 weeks after first intervention session |