Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Study Overview
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Brief Summary
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Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

Detailed Description
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The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.

Official Title
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Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Conditions
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Breast Cancer Female, Insomnia

Intervention / Treatment
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* Behavioral: Mindfulness-Based Therapy
* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer completed active treatment (surgery, radiation, chemotherapy) at least three months prior within 5 years of treatment or still on adjuvant therapy Completes informed consent to participate Exclusion Criteria: sleep apnea or restless leg syndrome practicing mindfulness techniques >1/wk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I<br>Cognitive Behavioral Therapy for Insomnia | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature.<br>|
| Experimental: Mindfulness<br>Mindfulness-Based Therapy | Behavioral: Mindfulness-Based Therapy<br>* Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia | Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia) | Nine weeks | 
| Change in Insomnia | Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse) | Nine weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | Measured via the FACT-Cog (Scale 0-132; higher is better) | Nine weeks | 
| Change in cognitive function | Measured via the Montreal Cognitive Assessment (MOCA) | Nine weeks | 
| Change in Fatigue | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse) | Nine weeks | 
| Change in Insomnia | Measured using an actigraph | Nine weeks |