A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Skaraborg Hospital
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Skaraborg Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 19, 2014