- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880799
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:
- 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
Exclusion Criteria:
- AJCC Stage IV breast cancer
- Unwilling to fill out surveys for the study
- Patients with a distant recurrence
- 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.
General Publications
- 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. Erratum In: Ann Surg Oncol. 2017 Mar 27;:
- 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.
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
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Mindfulness Session
-
Stanford UniversityCompletedBurnout | Anxiety DepressionUnited States
-
Wake Forest University Health SciencesCompleted
-
University of OsloOslo University HospitalCompletedPain, Postoperative | Breast Cancer | FatigueNorway
-
Duke UniversityTerminatedDepression | Cancer | Anxiety | Sickle Cell Disease | Virtual RealityUnited States
-
Posit Science CorporationVA Connecticut Healthcare SystemCompletedMild Traumatic Brain InjuryUnited States
-
Hospices Civils de LyonNot yet recruiting
-
University Hospital, Strasbourg, FranceCompleted
-
KU LeuvenKom Op Tegen KankerEnrolling by invitationColorectal CancerBelgium
-
Institut de cancérologie Strasbourg EuropeCompleted