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Mindfulness for Breast Cancer Pain and Anxiety

This study is exploring whether daily meditation can help women with newly diagnosed breast cancer manage pain and anxiety before and after surgery. Participants will practice two guided meditations for a total of 12 minutes each day. The study aims to see if this practice can reduce pain, measured at 12 weeks after surgery, compared to usual care. You may be able to join if you are a woman, 18 or older, newly diagnosed with breast cancer, and scheduled for primary surgical treatment. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 24 women. It is not specified if it is randomized or blinded.
What's involved
You would be asked to meditate twice daily, once in the morning and once before bed, for a total of 12 minutes per day. Surgical treatment and postoperative care will follow your surgeon's usual practice.
Compensation
Not stated in the trial record.
Follow-up
Pain will be measured at 12 weeks after surgery.

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NCT04049214

Perioperative Mindfulness Proposal

Recruiting
NAAges 18+InterventionalTreatment
Hoag Memorial Hospital Presbyterian
~24 participants
Updated 2024-10-15 on ClinicalTrials.gov
What's tested:Meditation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Will daily meditation change pain in undergoing primary surgical treatment for newly diagnosed breast cancer, utilizing the MD Anderson Cancer Center Brief Pain Inventory (short form)
Measured over 12 weeks

Conditions

Breast Cancer
DCIS

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Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

1 sites across 1 states
California1

Who to contact

Melinda Epstein, PhD
[email protected]
949-764-5543
Email the study team

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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).

What this trial measures

  • Will daily meditation change pain in undergoing primary surgical treatment for newly diagnosed breast cancer, utilizing the MD Anderson Cancer Center Brief Pain Inventory (short form)12 weeks

    Baseline pain assessment will be administered after informed consent is obtained. One week before definitive breast cancer surgery research subjects will complete a one on one education session regarding meditation practice with a wellness coach (AW), and complete a baseline NCCN distress survey. They will begin a daily meditation practice. Two guided meditations will be provided to participants. They will be asked to meditate twice daily, once in the morning once before bed, for a total time of 12 minutes per day. Surgical treatment and postoperative care will be provided by surgeon preference and usual practice, including post-operative pain medications. For 12 weeks patients will maintain a daily meditation log, medication log and complete daily pain assessment questionnaire using the MD Anderson Cancer Center Brief Pain Inventory (short form)