A Study of a Mindfulness-Based Intervention with a Wearable Wellness Brain Sensing Device in Newly Diagnosed Breast Cancer Patients Undergoing Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000498
Sponsor Protocol Number: 15-000498
About this study
The purpose of this study is to determine the usefulness and effectiveness of Muse, a brain sensing headband intervention, to affect quality of life, stress, fatigue and sleep in newly diagnosed breast cancer patients who are undergoing surgical treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women newly diagnosed with breast cancer
- Planning to undergo breast cancer surgical treatment
- Able to complete 7 days on intervention prior to the pre-surgical visit and/or prior to the second set of surveys
- Able to provide informed consent
- Able to complete all aspects of this trial
- Willing to use an iPhone, iPad, or Android device
- Between 20-75 years of age
Exclusion Criteria:
- Cancer patients currently (within the past 3 weeks) practicing mindfulness training on a regular basis
- Cancer patients currently (within the past 3 weeks) participating in integrative medicine therapies to improve symptoms and/or quality of life
- Cancer patient currently (within 3 weeks) enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients’ QOL, stress or fatigue
- Pregnant or breast feeding
- Receiving neoadjuvant chemotherapy
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Sandhya Pruthi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available