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

January 19, 2021 updated by: Katharine Yao, MD, NorthShore University HealthSystem
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to identify if a mindfulness intervention is feasible before the participant has their surgical consultation. The secondary aim is to measure the impact of the mindfulness intervention on participant reported outcomes including anxiety, quality of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be contacted over the phone after the patient learns of their diagnosis but prior to their surgical appointment to discuss surgical options. Verbal consent will be obtained over the phone and the participant will be directed to complete an online survey to answer baseline questions on their anxiety and quality of life as well as to provide their contact information and availability in order to schedule a mindfulness session with a certified mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise geared to help women apply these techniques to the decisional making process. The goal is to empower women to approach their diagnosis and treatment decisions with greater stability and improve their ability to focus on their values and preferences instead of just focusing on the diagnosis. This will be measured by administering patient reported outcomes (PROs) via REDCap online surveys at three timepoints. The first PRO "baseline survey" is administered after the participant enrolls but before the mindfulness session. The second PRO "before surgery survey" is completed after the surgical consultation but prior to the scheduled surgery. The final PRO "6-month survey" is administered 6 months after the surgery to measure quality of life, anxiety, and participant satisfaction with the mindfulness program. 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem

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.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. AJCC Stage IV breast cancer
  2. Unwilling to fill out surveys for the study
  3. Patients with a distant recurrence
  4. Patients unaware of their diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Intervention
Newly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment.
one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes on anxiety
Time Frame: 2 years
using the HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS); multiple choice, 4 point range scale. Examples: a. Most of the time b. A lot of the time c. From time to time, occasionally d. Not at all
2 years
Patient Reported Outcomes on fear of recurrence
Time Frame: 2 years
using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Scale ranging from 1-strongly disagree to 5-strongly agree. Example: Because cancer is unpredictable, I feel I cannot plan for the future. (1 -Strongly Disagree,2- Disagree,3- Not Certain,4- Agree 5-Strongly Agree)
2 years
Patient Reported Outcomes on quality of life
Time Frame: 2 years
utilizing the LINEAR ANALOGUE SELF ASSESSMENT (LASA) scale; Scale ranging from 0-10 with 0-being as bad as it can be, and 10 being as good as it can be. Last question on anxiety is flipped, 0-being no anxiety, and 10-being anxiety is as bad as it can be.
2 years
Patient Reported Outcomes on decisional satisfaction
Time Frame: 2 years
Using the Decisional satisfaction questionnaire. Scale ranges 1-4 with 1-being very dissatisfied, to 4-very satisfied. Example: With your breast area in mind, in the past 2 weeks, how satisfied or dissatisfied have you been with How you look in the mirror clothed? 1-very dissatisfied 2-somewhat dissatisfied 3-somewhat satisfied 4-very satisfied;
2 years
Patient Reported Outcomes on mindfulness outcome
Time Frame: 2 years
using the Mindfulness outcome measures (MeditationHX) Scale Ranges from 1-5 (1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much) Example: Overall, I am satisfied with my experience participating in this research program (1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much)
2 years
Patient Reported Outcomes and value concordant decision making
Time Frame: 2 years
ratio measured by a formula used in previous studies
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Katharine Yao, MD, NorthShore University HealthSystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

February 8, 2020

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • EH18-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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