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
  Purpose

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 Intervention
Cancer
Behavioral: mindfulness based stress reduction program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

Resource links provided by NLM:


Further study details as provided by Belgian Federal Public Service, Food Chain Safety and Environment:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074528

Contacts
Contact: Aisha Cortoos, PhD +32 2 477 55 63 aisha.cortoos@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Aisha Cortoos, PhD    +32 2 477 55 63    aisha.cortoos@uzbrussel.be   
Principal Investigator: Aisha Cortoos, PhD         
Principal Investigator: Ineke Van Mulders, MPsy         
Principal Investigator: Christiaan Schotte, PhD         
Sponsors and Collaborators
Belgian Federal Public Service, Food Chain Safety and Environment
Investigators
Principal Investigator: Christiaan Schotte, PhD UZ Brussel
  More Information

No publications provided

Responsible Party: Prof. Dr. Christiaan Schotte, Professor, Belgian Federal Public Service, Food Chain Safety and Environment
ClinicalTrials.gov Identifier: NCT01074528     History of Changes
Other Study ID Numbers: SCV2010
Study First Received: February 18, 2010
Last Updated: January 28, 2015
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Belgian Federal Public Service, Food Chain Safety and Environment:
cancer patients
relatives or partners of cancer patients

ClinicalTrials.gov processed this record on July 07, 2015