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

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: NCT01074528
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: mindfulness based stress reduction program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Study Start Date : April 2010
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017
Arms and Interventions
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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 Name: MBSR
No Intervention: control group
patients who have to wait before entering the MBSR program or who do not want to follow this program


Outcome Measures
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Primary Outcome Measures :
  1. quality of life (FACT) before training [ Time Frame: day 1 ]
  2. Quality of life (FACT) after training [ Time Frame: day 48 ]

Secondary Outcome Measures :
  1. Cancer Coping Questionnaire (CCQ) [ Time Frame: day 1 ]
  2. Profile Of Mood Scale (POMS) [ Time Frame: day 1 ]
  3. Perceived Stress Scale (PSS) [ Time Frame: day 1 ]
  4. Freiburg Mindfulness Scale [ Time Frame: day 1 ]
  5. Cancer Coping Questionnaire (CCQ) [ Time Frame: day 48 ]
  6. Profile of Mood Scale (POMS) [ Time Frame: day 48 ]
  7. Perceived Stress Scale (PSS) [ Time Frame: day 48 ]
  8. Freiburg Mindfulness Inventory (FMI) [ Time Frame: day48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01074528


Locations
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Belgium
UZ Brussel
Brussel, Belgium, 1090
Sponsors and Collaborators
Belgian Federal Public Service, Food Chain Safety and Environment
Investigators
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Principal Investigator: Christiaan Schotte, PhD Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Prof. Dr. Christiaan Schotte, Professor, Belgian Federal Public Service, Food Chain Safety and Environment
ClinicalTrials.gov Identifier: NCT01074528    
Other Study ID Numbers: SCV2010
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Keywords provided by Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment:
cancer patients
relatives or partners of cancer patients