A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
This study is currently recruiting participants.
Verified May 2012 by Skaraborg Hospital
Sponsor:
Skaraborg Hospital
Information provided by (Responsible Party):
Elisabeth Kenne Sarenmalm, Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT01591915
First received: May 2, 2012
Last updated: May 3, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: MBSR |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Skaraborg Hospital:
Primary Outcome Measures:
- The efficacy of Mindfulness Based Stress Reduction on mood disorders [ Time Frame: up to 5 years follow up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Coping capacity and health-related quality of life [ Time Frame: up to 5 years follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: MBSR
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.
|
Other: MBSR
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.
|
| No Intervention: Standard care |
Other: MBSR
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.
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591915
Contacts
| Contact: Elisabeth Kenne Sarenmalm, PhD | +46 500 432968 | elisabeth.kenne.sarenmalm@vgregion.se |
Locations
| Sweden | |
| Skaraborg Hospital | Recruiting |
| Skövde, Western Region, Sweden, SE-541 85 | |
| Contact: Anna-Lena Emanuelsson-Loft +46500431078 | |
| Principal Investigator: Elisabeth Kenne Sarenmalm, PhD | |
Sponsors and Collaborators
Skaraborg Hospital
More Information
No publications provided
| Responsible Party: | Elisabeth Kenne Sarenmalm, Researcher, Skaraborg Hospital |
| ClinicalTrials.gov Identifier: | NCT01591915 History of Changes |
| Other Study ID Numbers: | 499-09 |
| Study First Received: | May 2, 2012 |
| Last Updated: | May 3, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Skaraborg Hospital:
|
Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013