Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women 20-75 years old
- •Diagnosed with breast cancer
- •Scheduled to begin chemotherapy at Mayo Clinic Rochester
Exclusion Criteria
- •Practicing mindfulness
Arms & Interventions
Mindfulness Intervention
Mindfulness intervention
Intervention: Mindfulness (Behavioral)
Outcomes
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(7-8 months)
Investigators
Daniela L. Stan, M.D
Daniela Stan, MD
Mayo Clinic