Insomnia
Conditions
Keywords
Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer
Brief summary
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
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.
Interventions
BEHAVIORALCBT
BEHAVIORALMBSR
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | Baseline to 6 weeks and 6 weeks to 12 weeks | Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Fatigue Inventory (BFI) | Baseline to 6 weeks and 6 weeks to 12 weeks | Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions. |
| Change in Depression, Anxiety and Stress Scale 21 (DASS21) | Baseline to 6 weeks and 6 weeks to 12 weeks | Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions |
| Number of patients who respond to CBT vs MBSR based on Ethnicity | 12 weeks | Variations in efficacy outcomes based on ethnicity |
Countries
United States
Outcome results
None listed