The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer

NCT03880799 | Completed

• 1 other identifier: EH18-203
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators propose to pilot test a brief, mindfulness shared decision making intervention that begins shortly after receiving a diagnosis of breast cancer. A mindfulness instructor will conduct an hour long session with consented participants before the scheduled surgical appointment. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety. To measure this endpoint, participants will complete three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys will include questions on quality of life, anxiety, and participant satisfaction with the mindfulness program.

Conditions

Breast Cancer; Surgery

Keywords

Mindfulness; Surgical Decision Making

Outcome Measures

Primary Outcomes (8)

• Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.

  The number of patients who have successfully completed their mindfulness session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.

  1 year

• Acceptability of a mindfulness intervention following the surgical consultation measured by adherence to the follow up session.

  The number of patients who have successfully completed their mindfulness follow up session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.

  1 year

• Participant feedback via Questionnaire on the usefulness of the mindfulness experience on their emotional management and decision making process.

  Two sets of questions asking about level of satisfaction with the mindfulness experience and how it pertains to their treatment decision satisfaction with responses being; 1. Not at all, 2. A little bit, 3. Somewhat, 4. Quite a bit, 5. Very much;

  1 year

• Feasibility of a mindfulness intervention prior to the surgical consultation by a single question regarding mode of communication participants prefer.

  Options include by phone, video conference, or in-person

  1 year

• Feasibility of a mindfulness intervention prior to the surgical consultation by calculating proportion of participants who consent to the study.

  Measurement will be done by looking at the ratio of participants approached versus participants consented to the study.

  1 year

• Feasibility of a mindfulness intervention prior to the surgical consultation by proportion of participants who have contact with the mindfulness teacher.

  Measurement will be done by looking at the ratio of participants consented versus participants completed the mindfulness intervention with the teacher.

  1 year

• Feasibility of a mindfulness intervention prior to the surgical consultation by measuring the length of time to schedule the participant with the mindfulness teacher.

  This will be measured by comparing date the participant consented on the study to the date participant had successfully scheduled their mindfulness session.

  1 year

• Feasibility of a mindfulness intervention prior to the surgical consultation by adherence to the mindfulness excercises.

  The mindfulness instructor will conduct a follow-up session with the participant following their surgical consultation and measure the number of times the participant listened to the audio recordings given to them following their mindfulness session but prior to their surgical consultation.

  1 year

Secondary Outcomes (6)

• Patient Reported Outcomes on anxiety

  2 years

• Patient Reported Outcomes on fear of recurrence

  2 years

• Patient Reported Outcomes on quality of life

  2 years

• Patient Reported Outcomes on decisional satisfaction

  2 years

• Patient Reported Outcomes on mindfulness outcome

  2 years

Study Arms (1)

Mindfulness Intervention

EXPERIMENTAL

Newly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment.

Behavioral: Mindfulness Session

Interventions

Mindfulness Session BEHAVIORAL

one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient

Mindfulness Intervention

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females \>20 and \< 70 years of age
• History of contralateral breast cancer in the past is acceptable
• Patients seeking second opinion for diagnosis are eligible
• Clinical AJCC stage 0-III breast cancer
• Patients who have an in breast tumor recurrence are eligible
• English Speaking
• Willing to fill out surveys required for the study
• Gene mutation carriers are eligible
• Neoadjuvant therapy patients are eligible

You may not qualify if:

• AJCC Stage IV breast cancer
• Unwilling to fill out surveys for the study
• Patients with a distant recurrence
• Patients unaware of their diagnosis

Sponsors & Collaborators

• Endeavor Health: lead
• Northwestern University: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (2)

• Yao K, Belkora J, Bedrosian I, Rosenberg S, Sisco M, Barrera E, Kyrillios A, Tilburt J, Wang C, Rabbitt S, Pesce C, Simovic S, Winchester DJ, Sepucha K. Impact of an In-visit Decision Aid on Patient Knowledge about Contralateral Prophylactic Mastectomy: A Pilot Study. Ann Surg Oncol. 2017 Jan;24(1):91-99. doi: 10.1245/s10434-016-5556-x. Epub 2016 Sep 21.

  PMID: 27654108 BACKGROUND

• Sepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG Jr. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns. 2007 Feb;65(2):261-9. doi: 10.1016/j.pec.2006.08.007. Epub 2006 Oct 4.

  PMID: 17023138 BACKGROUND

Related Links

• Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katharine Yao, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Surgical Oncology

Model Details: non-randomized feasibility study

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: March 19, 2019
• Study Start: November 8, 2018
• Primary Completion: February 8, 2020
• Study Completion: February 10, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)