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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074528
First Posted: February 24, 2010
Last Update Posted: July 17, 2017
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.
Information provided by (Responsible Party):
Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment
February 18, 2010
February 24, 2010
July 17, 2017
April 2010
April 2017   (Final data collection date for primary outcome measure)
  • quality of life (FACT) before training [ Time Frame: day 1 ]
  • Quality of life (FACT) after training [ Time Frame: day 48 ]
quality of life (FACT) [ Time Frame: T1 and T1+8 weeks ]
Complete list of historical versions of study NCT01074528 on ClinicalTrials.gov Archive Site
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: day 1 ]
  • Profile Of Mood Scale (POMS) [ Time Frame: day 1 ]
  • Perceived Stress Scale (PSS) [ Time Frame: day 1 ]
  • Freiburg Mindfulness Scale [ Time Frame: day 1 ]
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: day 48 ]
  • Profile of Mood Scale (POMS) [ Time Frame: day 48 ]
  • Perceived Stress Scale (PSS) [ Time Frame: day 48 ]
  • Freiburg Mindfulness Inventory (FMI) [ Time Frame: day48 ]
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: T1 and T1+8weeks ]
  • Profile Of Mood Scale (POMS) [ Time Frame: T1 and T1+8 weeks ]
  • Perceived Stress Scale (PSS) [ Time Frame: T1 and T1+8 weeks ]
  • Freiburg Mindfulness Scale [ Time Frame: T1 and T1+8 weeks ]
Not Provided
Not Provided
 
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Cancer
Behavioral: mindfulness based stress reduction program
8-week mindfulness training program
Other Name: MBSR
  • Experimental: mindfulness based stress reduction
    8-week mindfulness based stress reduction program
    Intervention: Behavioral: mindfulness based stress reduction program
  • No Intervention: control group
    patients who have to wait before entering the MBSR program or who do not want to follow this program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2017
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01074528
SCV2010
No
Not Provided
Not Provided
Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment
Belgian Federal Public Service, Food Chain Safety and Environment
Not Provided
Principal Investigator: Christiaan Schotte, PhD Universitair Ziekenhuis Brussel
Belgian Federal Public Service, Food Chain Safety and Environment
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP