Insomnia Interventions in Cancer Survivors

Study Overview
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Brief Summary
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This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

Detailed Description
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The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.

Official Title
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Insomnia Interventions in Cancer Survivors

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: MBSR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent age 18 and over diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper Self reported insomnia Not currently taking any medications to treat insomnia No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Cognitive Behavioral Therapy (CBT) | Behavioral: CBT<br> <br> * Other names: cognitive behavioral therapy;|
| Active Comparator: Arm 2<br>Mindfulness Based Stress Reduction (MBSR) | Behavioral: MBSR<br> <br> * Other names: mindfulness based stress reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions. | Baseline to 6 weeks and 6 weeks to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Fatigue Inventory (BFI) | Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions. | Baseline to 6 weeks and 6 weeks to 12 weeks | 
| Change in Depression, Anxiety and Stress Scale 21 (DASS21) | Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions | Baseline to 6 weeks and 6 weeks to 12 weeks | 
| Number of patients who respond to CBT vs MBSR based on Ethnicity | Variations in efficacy outcomes based on ethnicity | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer