Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

July 13, 2017 updated by: Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment
The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress Reduction (MBSR) training program that is offered in the investigator hospital, more specifically on quality of life, coping strategies and partner relationship by using questionnaires. To asses the possible impact of this treatment on the latter domain, partners of the patients with a cancer diagnosis are invited to join the training program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with breast cancer often experience anxiety, depression, stress and reduced quality of life. As such, there is an increased interest in the implementation of the Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a structured group program that aims at reducing stress levels by enhancing awareness of the present moment in combination with a non-judgemental attitude.

The study evaluates the effects of an 8-week MBSR program on quality of life, mood, depression, stress and coping skills in breast cancer patients.

Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel participate in the MBSR program. Before and after the training program patients filled out questionnaires evaluating quality of life, coping skills, emotional functioning, stress and aspects of mindfulness.

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

  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For patients:

  • Cancer diagnosis
  • Between the age of 18 until 70
  • Dutch speaking

For partners:

  • between the age of 18 until 70
  • dutch speaking

Exclusion Criteria:

for patients and partners:

  • Ongoing radiation therapy
  • Psychiatric disorders
  • Previous experience with mindfulness or meditation related techniques
  • Pregnancy
  • No or insufficient understanding of the Dutch language

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mindfulness based stress reduction
8-week mindfulness based stress reduction program
Behavioral: mindfulness based stress reduction program
8-week mindfulness training program
Other Names:
  • MBSR
No Intervention: control group
patients who have to wait before entering the MBSR program or who do not want to follow this program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life (FACT) before training
Time Frame: day 1
day 1
Quality of life (FACT) after training
Time Frame: day 48
day 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer Coping Questionnaire (CCQ)
Time Frame: day 1
day 1
Profile Of Mood Scale (POMS)
Time Frame: day 1
day 1
Perceived Stress Scale (PSS)
Time Frame: day 1
day 1
Freiburg Mindfulness Scale
Time Frame: day 1
day 1
Cancer Coping Questionnaire (CCQ)
Time Frame: day 48
day 48
Profile of Mood Scale (POMS)
Time Frame: day 48
day 48
Perceived Stress Scale (PSS)
Time Frame: day 48
day 48
Freiburg Mindfulness Inventory (FMI)
Time Frame: day48
day48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belgian Federal Public Service, Food Chain Safety and Environment

Investigators

  • Principal Investigator: Christiaan Schotte, PhD, Universitair Ziekenhuis Brussel

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

April 1, 2010

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCV2010

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.

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