Perioperative Mindfulness Proposal
Recruiting · NCT04049214 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoag Memorial Hospital Presbyterian
View the official record on ClinicalTrials.gov →Interventions studied
Meditation
What this trial is about
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 breast cancer and its treatment.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed across 1 US state.
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States