Back to resultsInsomnia Interventions in Cancer Survivors
Primary Purpose
Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
MBSR
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer
Eligibility Criteria
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.
Sites / Locations
- MD Anderson Cancer Center at Cooper
- MD Anderson Cancer Center at Cooper
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Cognitive Behavioral Therapy (CBT)
Mindfulness Based Stress Reduction (MBSR)
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index
Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.
Secondary Outcome Measures
Change in Brief Fatigue Inventory (BFI)
Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.
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
Number of patients who respond to CBT vs MBSR based on Ethnicity
Variations in efficacy outcomes based on ethnicity
Full Information
NCT ID
NCT02783079
First Posted
February 12, 2016
Last Updated
May 25, 2016
Sponsor
The Cooper Health System
1. Study Identification
Unique Protocol Identification Number
NCT02783079
Brief Title
Insomnia Interventions in Cancer Survivors
Official Title
Insomnia Interventions in Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT)
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Mindfulness Based Stress Reduction (MBSR)
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Other Intervention Name(s)
mindfulness based stress reduction
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.
Time Frame
Baseline to 6 weeks and 6 weeks to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Brief Fatigue Inventory (BFI)
Description
Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.
Time Frame
Baseline to 6 weeks and 6 weeks to 12 weeks
Title
Change in Depression, Anxiety and Stress Scale 21 (DASS21)
Description
Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions
Time Frame
Baseline to 6 weeks and 6 weeks to 12 weeks
Title
Number of patients who respond to CBT vs MBSR based on Ethnicity
Description
Variations in efficacy outcomes based on ethnicity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
MD Anderson Cancer Center at Cooper
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Contact:
Phone
856-735-6100
Facility Name
MD Anderson Cancer Center at Cooper
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Contact:
Phone
856-325-6750
12. IPD Sharing Statement
Learn more about this trial
Insomnia Interventions in Cancer Survivors
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