Back to resultsA Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MBSR
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy
Exclusion Criteria:
- patients with advanced illness at diagnosis
- patients previously used MBSR
Sites / Locations
- Skaraborg Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
MBSR self care program including weekly sessions
MBSR self care program
Standard care
Arm Description
Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Participants will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 hours.
Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week.
Outcomes
Primary Outcome Measures
The efficacy of Mindfulness Based Stress Reduction on mood disorders
Secondary Outcome Measures
Coping capacity and health-related quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01591915
Brief Title
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Official Title
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skaraborg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBSR self care program including weekly sessions
Arm Type
Experimental
Arm Description
Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Participants will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 hours.
Arm Title
MBSR self care program
Arm Type
Experimental
Arm Description
Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week.
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
MBSR
Intervention Description
Participants in Intervention 1 and Intervention 2 will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 min sessions, 6 days/week. Participants will be provided information material including a book of 20 pages introduction to mindfulness training, self-instructing CD, diary and training program. Only participants in Intervention 1 will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 h. Led by a certified MBSR instructor, these weekly group sessions are focused on participant's experiences of mindfulness, and include yoga and meditation training. Four registered nurses, skilled in patient learning, have been educated as certified MBSR instructors.
Primary Outcome Measure Information:
Title
The efficacy of Mindfulness Based Stress Reduction on mood disorders
Time Frame
up to 5 years follow up
Secondary Outcome Measure Information:
Title
Coping capacity and health-related quality of life
Time Frame
up to 5 years follow up
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy
Exclusion Criteria:
patients with advanced illness at diagnosis
patients previously used MBSR
Facility Information:
Facility Name
Skaraborg Hospital
City
Skövde
State/Province
Western Region
ZIP/Postal Code
SE-541 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24088535
Citation
Kenne Sarenmalm E, Martensson LB, Holmberg SB, Andersson BA, Oden A, Bergh I. Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complement Altern Med. 2013 Oct 2;13:248. doi: 10.1186/1472-6882-13-248.
Results Reference
derived
Learn more about this trial
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
We'll reach out to this number within 24 hrs