Breast CancerMEDITATE-BCNCT03880799
The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
A study testing Mindfulness Session in people with Breast Cancer and Surgery, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- Mindfulness Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2018to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Willing to fill out surveys required for the study
- Gene mutation carriers are eligible
- Neoadjuvant therapy patients are eligible
Who cannot join
- AJCC Stage IV breast cancer
- Unwilling to fill out surveys for the study
- Patients with a distant recurrence
- Patients unaware of their diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Surgery
- Being tested
- Mindfulness Session
- Keywords
- Mindfulness, Surgical Decision Making
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness SessionBehavioural
one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | Newly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment. Receives: Behavioral: Mindfulness Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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;
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
Patient Reported Outcomes on anxiety
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
Measured: 2 years
Patient Reported Outcomes on fear of recurrence
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)
Measured: 2 years
Patient Reported Outcomes on quality of life
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.
Measured: 2 years
Patient Reported Outcomes on decisional satisfaction
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;
Measured: 2 years
Patient Reported Outcomes on mindfulness outcome
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)
Measured: 2 years
Patient Reported Outcomes and value concordant decision making
ratio measured by a formula used in previous studies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start8 Nov 2018
- Primary completion8 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomized feasibility study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Katharine Yao, MD, Endeavor Health
- Investigators
- Katharine Yao, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880799
- Sponsor's protocol ID
- EH18-203
- Acronym
- MEDITATE-BC
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27654108Sepucha 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.
PubMed 17023138
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
- ClinicalTrials.gov ID
- NCT03880799
- Acronym / sponsor ID
- MEDITATE-BC / EH18-203
- Conditions
- Breast Cancer, Surgery
- Keywords
- Mindfulness, Surgical Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized feasibility study
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness SessionNewly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- AJCC Stage IV breast cancer
- Unwilling to fill out surveys for the study
- Patients with a distant recurrence
- Patients unaware of their diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Sessionone hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient | Behavioural | Mindfulness Intervention |
Primary outcome
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.
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.
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;
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
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.
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.
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.
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.
6 secondary outcomes
Patient Reported Outcomes on anxiety
Time frame: 2 years
Patient Reported Outcomes on fear of recurrence
Time frame: 2 years
Patient Reported Outcomes on quality of life
Time frame: 2 years
Patient Reported Outcomes on decisional satisfaction
Time frame: 2 years
Patient Reported Outcomes on mindfulness outcome
Time frame: 2 years
Patient Reported Outcomes and value concordant decision making
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 27654108Yao 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.
- Background: PubMed 17023138Sepucha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Yao, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Session in people with Breast Cancer and Surgery, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention. (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880799, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.