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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01591915
Recruitment Status : Enrolling by invitation
First Posted : May 4, 2012
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Breast Cancer Other: MBSR

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Study Start Date : January 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The efficacy of Mindfulness Based Stress Reduction on mood disorders [ Time Frame: up to 5 years follow up ]

Secondary Outcome Measures :
  1. Coping capacity and health-related quality of life [ Time Frame: up to 5 years follow up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591915


Locations
Sweden
Skaraborg Hospital
Skövde, Western Region, Sweden, SE-541 85
Sponsors and Collaborators
Skaraborg Hospital
More Information

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
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Elisabeth Kenne Sarenmalm, 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