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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Belgian Federal Public Service, Food Chain Safety and Environment.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Belgian Federal Public Service, Food Chain Safety and Environment
ClinicalTrials.gov Identifier:
NCT01074528
First received: February 18, 2010
Last updated: June 16, 2011
Last verified: February 2010
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 2012
Estimated Primary Completion Date: April 2012 (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

  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
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: Christiaan Schotte, UZ Brussel
ClinicalTrials.gov Identifier: NCT01074528     History of Changes
Other Study ID Numbers: SCV2010
Study First Received: February 18, 2010
Last Updated: June 16, 2011
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 May 23, 2013