The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
Condition: Breast Cancer; Surgery
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Session
Intervention type(s): Behavioral
Intervention description(s): one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient
Intervention model: Single Group Assignment
Intervention model description: non-randomized feasibility study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Surgical Decision Making