Clinical trial NCT03880799: The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
Official title: The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Surgery
Keywords: Mindfulness
Surgical Decision Making
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2019-03-19
Enrollment: 22
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomized feasibility study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.
timeFrame: 1 year
measure: Acceptability of a mindfulness intervention following the surgical consultation measured by adherence to the follow up session.
timeFrame: 1 year
measure: Participant feedback via Questionnaire on the usefulness of the mindfulness experience on their emotional management and decision making process.
timeFrame: 1 year
measure: Feasibility of a mindfulness intervention prior to the surgical consultation by a single question regarding mode of communication participants prefer.
timeFrame: 1 year
measure: Feasibility of a mindfulness intervention prior to the surgical consultation by calculating proportion of participants who consent to the study.
timeFrame: 1 year
measure: Feasibility of a mindfulness intervention prior to the surgical consultation by proportion of participants who have contact with the mindfulness teacher.
timeFrame: 1 year
measure: Feasibility of a mindfulness intervention prior to the surgical consultation by measuring the length of time to schedule the participant with the mindfulness teacher.
timeFrame: 1 year
measure: Feasibility of a mindfulness intervention prior to the surgical consultation by adherence to the mindfulness excercises.
timeFrame: 1 year
Secondary outcomes:
measure: Patient Reported Outcomes on anxiety
timeFrame: 2 years
measure: Patient Reported Outcomes on fear of recurrence
timeFrame: 2 years
measure: Patient Reported Outcomes on quality of life
timeFrame: 2 years
measure: Patient Reported Outcomes on decisional satisfaction
timeFrame: 2 years
measure: Patient Reported Outcomes on mindfulness outcome
timeFrame: 2 years
measure: Patient Reported Outcomes and value concordant decision making
timeFrame: 2 years
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Katharine Yao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.