- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074528
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussel, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mindfulness based stress reduction
8-week mindfulness based stress reduction program
|
8-week mindfulness training program
Other Names:
|
No Intervention: control group
patients who have to wait before entering the MBSR program or who do not want to follow this program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life (FACT) before training
Time Frame: day 1
|
day 1
|
Quality of life (FACT) after training
Time Frame: day 48
|
day 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cancer Coping Questionnaire (CCQ)
Time Frame: day 1
|
day 1
|
Profile Of Mood Scale (POMS)
Time Frame: day 1
|
day 1
|
Perceived Stress Scale (PSS)
Time Frame: day 1
|
day 1
|
Freiburg Mindfulness Scale
Time Frame: day 1
|
day 1
|
Cancer Coping Questionnaire (CCQ)
Time Frame: day 48
|
day 48
|
Profile of Mood Scale (POMS)
Time Frame: day 48
|
day 48
|
Perceived Stress Scale (PSS)
Time Frame: day 48
|
day 48
|
Freiburg Mindfulness Inventory (FMI)
Time Frame: day48
|
day48
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christiaan Schotte, PhD, Universitair Ziekenhuis Brussel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCV2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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