Status:
RECRUITING
Perioperative Mindfulness Proposal
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Breast Cancer
DCIS
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if a regular meditation and breath work practice started before surgery and continued through post-surgical recovery can improve anxiety and pain related to b...
Detailed Description
Breast cancer affects 1 in 8 women in the United States and the majority are managed surgically as part of their primary treatment. Annually over 800 women at Hoag are treated surgically for breast ca...
Eligibility Criteria
Inclusion
- Females 18 years of age or older
- Subject must be able to speak and read English
- Newly diagnosed with primary breast cancer
- Will receive primary surgical treatment for their breast cancer diagnosis.
- Undergoing lumpectomy with or without autologous reconstruction with or without contralateral surgery for symmetry with or without IORT or simple mastectomy without reconstruction
- Breast cancer or DCIS
Exclusion
- Recurrent breast cancer
- Current or history of major psychiatric diagnosis.
- Subjects who are receiving neo-adjuvant chemotherapy
- Subjects undergoing modified radical mastectomy or reconstruction
- Subjects regular meditation practice within the past 12 months (defined as greater than twice weekly practice)
- Subjects unwilling or unable to complete study materials or comply with study visits
- Subjects with no access to email or a mobile phone (required to access meditations)
- Subjects undergoing surgery outside Hoag
- Subjects who have narcotic dependence as defined by regular weekly narcotic use before cancer diagnosis.
- Re-excision after lumpectomy (subjects who require re-excision after initial enrollment will be excluded from final analysis and dropped from the study).
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04049214
Start Date
July 31 2019
End Date
July 31 2025
Last Update
October 15 2024
Active Locations (1)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663