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

Breast Cancer Clinical Trial

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

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

• NCT number: NCT03880799
• Study type: Interventional
• Source: NorthShore University HealthSystem
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Completion date: February 10, 2020