- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591915
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
April 29, 2016 updated by: Elisabeth Kenne Sarenmalm, Skaraborg Hospital
The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Region
-
Skövde, Western Region, Sweden, SE-541 85
- Skaraborg Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
|
|
Experimental: MBSR self care program including weekly sessions
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 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.
|
Experimental: MBSR self care program
Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The efficacy of Mindfulness Based Stress Reduction on mood disorders
Time Frame: up to 5 years follow up
|
up to 5 years follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Coping capacity and health-related quality of life
Time Frame: up to 5 years follow up
|
up to 5 years follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
May 2, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 4, 2012
Study Record Updates
Last Update Posted (Estimate)
May 2, 2016
Last Update Submitted That Met QC Criteria
April 29, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 499-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Cecile LengacherCompletedBreast CancerUnited States
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-
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-
University of AarhusUnknown
-
Yale UniversityCompleted
-
Henry M. Jackson Foundation for the Advancement...UnknownTBI (Traumatic Brain Injury) | Chronic InsomniaUnited States
-
University of Dublin, Trinity CollegeFamily Carers IrelandTerminated