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

Status

Unknown

Conditions

Intervention / Treatment

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.

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

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.

Clinical Trials on Breast Cancer

Clinical Trials on MBSR

3
Subscribe