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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Belgian Federal Public Service, Food Chain Safety and Environment
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment
ClinicalTrials.gov Identifier:
NCT01074528
First received: February 18, 2010
Last updated: January 28, 2015
Last verified: January 2015

February 18, 2010
January 28, 2015
April 2010
April 2017   (final data collection date for primary outcome measure)
  • quality of life (FACT) before training [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Quality of life (FACT) after training [ Time Frame: day 48 ] [ Designated as safety issue: No ]
quality of life (FACT) [ Time Frame: T1 and T1+8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01074528 on ClinicalTrials.gov Archive Site
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Profile Of Mood Scale (POMS) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Perceived Stress Scale (PSS) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Freiburg Mindfulness Scale [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: day 48 ] [ Designated as safety issue: No ]
  • Profile of Mood Scale (POMS) [ Time Frame: day 48 ] [ Designated as safety issue: No ]
  • Perceived Stress Scale (PSS) [ Time Frame: day 48 ] [ Designated as safety issue: No ]
  • Freiburg Mindfulness Inventory (FMI) [ Time Frame: day48 ] [ Designated as safety issue: No ]
  • Cancer Coping Questionnaire (CCQ) [ Time Frame: T1 and T1+8weeks ] [ Designated as safety issue: No ]
  • Profile Of Mood Scale (POMS) [ Time Frame: T1 and T1+8 weeks ] [ Designated as safety issue: No ]
  • Perceived Stress Scale (PSS) [ Time Frame: T1 and T1+8 weeks ] [ Designated as safety issue: No ]
  • Freiburg Mindfulness Scale [ Time Frame: T1 and T1+8 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
200
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
Both
18 Years to 70 Years
No
Contact: Aisha Cortoos, PhD +32 2 477 55 63 aisha.cortoos@uzbrussel.be
Belgium
 
NCT01074528
SCV2010
No
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 UZ Brussel
Belgian Federal Public Service, Food Chain Safety and Environment
January 2015

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