Perioperative Mindfulness Proposal

NCT04049214 | Recruiting

• 1 other identifier: 173-18-CA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 breast cancer and its treatment.

Conditions

Breast Cancer; DCIS

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  12 weeks

Study Arms (1)

Meditation

OTHER

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.

Other: Meditation

Interventions

Meditation OTHER

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.

Meditation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1\. Females 18 years of age or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Meditation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Melinda Epstein, PhD

CONTACT

949-764-5543; clinicalresearch@hoag.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 8, 2019
• Study Start: July 31, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)