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Perioperative Mindfulness Proposal

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether regular meditation and breathing exercises can ease anxiety and pain linked to breast cancer and its treatment. It is for women age 18 or older with newly diagnosed breast cancer who will have certain types of surgery. The practice starts before surgery and continues during recovery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Able to speak and read English.
  • Newly diagnosed with breast cancer, including DCIS (cancer cells inside the breast’s milk ducts).
  • Will have surgery as the main treatment for breast cancer.
  • Having a lumpectomy (removal of the cancer and some nearby breast tissue) or a simple mastectomy (removal of the breast) without breast rebuilding.
  • With lumpectomy, you may also have breast rebuilding using your own tissue, surgery on the other breast to make them match, or radiation during surgery.

Who can't join

  • Breast cancer that has come back.
  • A current or past major mental health diagnosis, or dependence on narcotic pain medicines, defined here as regular weekly use before the cancer diagnosis.
  • Getting chemotherapy before surgery.
  • Having a modified radical mastectomy (removal of the breast and underarm lymph nodes) or breast rebuilding. The listing separately allows rebuilding with your own tissue during lumpectomy.
  • Practiced meditation more than twice a week within the past 12 months.
  • Unwilling or unable to finish study materials or attend study visits, or lacking access to email or a mobile phone to use the meditations.
  • Having surgery outside Hoag.
  • Having another surgery to remove more tissue after a lumpectomy. If this is needed after joining, you will leave the study and your results will not be included in the final analysis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA