RECRUITING

Perioperative Mindfulness Proposal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility Study to Determine the Effect of Meditation on Perioperative Pain and Distress in Newly Diagnosed Breast Cancer Patients

Quick Facts

Study Start:2019-07-31

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04049214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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).

Inclusion Criteria

Exclusion 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

* 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).

Contacts and Locations

Study Contact

Melinda Epstein, PhD

CONTACT

949-764-5543

clinicalresearch@hoag.org

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

United States

Collaborators and Investigators

Sponsor: Hoag Memorial Hospital Presbyterian

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-31

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2019-07-31

Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
DCIS