This trial is active, not recruiting.

Condition breast cancer
Treatment mindfulness
Phase phase 2
Sponsor Mayo Clinic
Start date April 2014
End date July 2015
Trial size 25 participants
Trial identifier NCT02067351, 13-008531


There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving chemotherapy for breast cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Mindfulness intervention
Meditation, body scan, yoga.

Primary Outcomes

Feasibility - percentage of patients recruited from those approached, percentage of patients who dropped off, percentage of patients who are compliant (attending more than 75% of recommended sessions)
time frame: While receiving chemotherapy (usually 4-5 months)

Secondary Outcomes

Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress
time frame: 7-8 months

Eligibility Criteria

Female participants from 20 years up to 75 years old.

inclusion criteria: - Women 20-75 years old - Diagnosed with breast cancer - Scheduled to begin chemotherapy at Mayo Clinic Rochester Exclusion criteria - Pregnant - Practicing mindfulness

Additional Information

Official title Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Principal investigator Daniela Stan, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.