Breast Cancer Female, Insomnia
Conditions
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.
Interventions
BEHAVIORALMindfulness-Based Therapy
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.
BEHAVIORALCognitive Behavioral Therapy for Insomnia
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.
Sponsors
George Washington University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia | Nine weeks | Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | Nine weeks | Measured via the FACT-Cog (Scale 0-132; higher is better) |
| Change in Fatigue | Nine weeks | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse) |
| Change in Insomnia | Nine weeks | Measured using an actigraph |
Countries
United States
Outcome results
None listed