Back to resultsComparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Primary Purpose
Breast Cancer Female, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Therapy
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female
Eligibility Criteria
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
Sites / Locations
- GW Center for Integrative Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CBT-I
Mindfulness
Arm Description
Cognitive Behavioral Therapy for Insomnia
Mindfulness-Based Therapy
Outcomes
Primary Outcome Measures
Change in Insomnia
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Change in Insomnia
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
Secondary Outcome Measures
Change in cognitive function
Measured via the FACT-Cog (Scale 0-132; higher is better)
Change in cognitive function
Measured via the Montreal Cognitive Assessment (MOCA)
Change in Fatigue
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)
Change in Insomnia
Measured using an actigraph
Full Information
NCT ID
NCT03328169
First Posted
October 24, 2017
Last Updated
August 14, 2018
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT03328169
Brief Title
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Official Title
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy for Insomnia
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness-Based Therapy
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Insomnia
Description
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Time Frame
Nine weeks
Title
Change in Insomnia
Description
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
Time Frame
Nine weeks
Secondary Outcome Measure Information:
Title
Change in cognitive function
Description
Measured via the FACT-Cog (Scale 0-132; higher is better)
Time Frame
Nine weeks
Title
Change in cognitive function
Description
Measured via the Montreal Cognitive Assessment (MOCA)
Time Frame
Nine weeks
Title
Change in Fatigue
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)
Time Frame
Nine weeks
Title
Change in Insomnia
Description
Measured using an actigraph
Time Frame
Nine weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
GW Center for Integrative Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
We'll reach out to this number within 24 hrs