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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Cognitive Behavioral Therapy (CBT) |
|
| Arm 2 | Active Comparator | Mindfulness Based Stress Reduction (MBSR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral |
|
| |
| MBSR |
| 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 |
| 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) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center at Cooper | Camden | New Jersey | 08103 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D064866 | Mindfulness |
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| Behavioral |
|
|
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 |
| MD Anderson Cancer Center at Cooper | Voorhees Township | New Jersey | 08043 | United States |
|
| D001523 |
| Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |