Back to resultsMindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
inclusion criteria:
- Women 20-75 years old
- Diagnosed with breast cancer
- Scheduled to begin chemotherapy at Mayo Clinic Rochester
Exclusion criteria
- Pregnant
- Practicing mindfulness
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness Intervention
Arm Description
Mindfulness intervention
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress
Stress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02067351
Brief Title
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Official Title
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Intervention
Arm Type
Experimental
Arm Description
Mindfulness intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Meditation, body scan, yoga.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress
Description
Stress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy
Time Frame
7-8 months
Other Pre-specified Outcome Measures:
Title
Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score
Description
Fatigue will be measured by the before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy
Time Frame
7-8 months
Title
Quality of life measured by the Functional Assessment of Cancer Therapy - Breast - statistically and clinically significant improvement in quality of life
Description
Quality of life will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy
Time Frame
7-8 months
Title
Sleep measured by the Pittsburgh Sleep Quality Index -statistically and clinically significant improvements in sleep
Description
Sleep will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy
Time Frame
7-8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
inclusion criteria:
Women 20-75 years old
Diagnosed with breast cancer
Scheduled to begin chemotherapy at Mayo Clinic Rochester
Exclusion criteria
Pregnant
Practicing mindfulness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Stan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
We'll reach out to this number within 24 hrs