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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: MBSR


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR self care program including weekly sessions<br>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<br>* 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.<br>|
| Experimental: MBSR self care program<br>Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. | Other: MBSR<br>* 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.<br>|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of Mindfulness Based Stress Reduction on mood disorders |  | up to 5 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping capacity and health-related quality of life |  | up to 5 years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life