Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedAugust 15, 2018
August 1, 2018
1.2 years
October 24, 2017
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Insomnia
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Nine weeks
Change in Insomnia
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
Nine weeks
Secondary Outcomes (4)
Change in cognitive function
Nine weeks
Change in cognitive function
Nine weeks
Change in Fatigue
Nine weeks
Change in Insomnia
Nine weeks
Study Arms (2)
CBT-I
ACTIVE COMPARATORCognitive Behavioral Therapy for Insomnia
Mindfulness
EXPERIMENTALMindfulness-Based Therapy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- sleep apnea or restless leg syndrome
- practicing mindfulness techniques \>1/wk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GW Center for Integrative Medicine
Washington D.C., District of Columbia, 20052, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 24, 2017
First Posted
November 1, 2017
Study Start
April 15, 2017
Primary Completion
June 28, 2018
Study Completion
June 28, 2018
Last Updated
August 15, 2018
Record last verified: 2018-08