Recruiting

Mindfulness

Sponsor:

Hoag Memorial Hospital Presbyterian

Code:

NCT04049214

Conditions

Breast Cancer

DCIS

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Meditation

Study Details

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

Study ID

NCT04049214

Start date

Jul 31, 2019

Status verified date

Oct, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Meditation

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.

Interventions

Meditation

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.

Primary outcome measure

  • 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) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Melinda Epstein, PhD

949-764-5543clinicalresearch@hoag.org

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Melinda Epstein, PhD

949-764-5543clinicalresearch@hoag.org

More Information

Sponsor

Hoag Memorial Hospital Presbyterian

Last update posted

Oct 15, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoag Memorial Hospital Presbyterian on 2024-10-15.