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NCT Number: NCT03880799

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness session

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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;

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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. 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)

  3. 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.

  4. 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;

  5. 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)

  6. Patient Reported Outcomes and value concordant decision making

    Time frame: 2 years

    ratio measured by a formula used in previous studies

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Northwestern University

Registry information

Acronym: MEDITATE-BC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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