Mindfulness-based Stress Reduction in Cancer Treatment
SASO
1 other identifier
interventional
117
1 country
1
Brief Summary
Emotional and mental symptoms are common consequences of cancer diagnosis and treatment. Coping with these symptoms seems to be influenced by interpretation of illness, locus of health control and spiritual attitudes in dealing with illness. Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in cancer patients. The aim of this study is to investigate the effect of a mindfulness-based day-care clinic group program on quality of life, anxiety and depression in cancer patients and to evaluate the association with coping styles, spiritual attitudes in dealing with illness, mindfulness and interpretation of illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 24, 2013
July 1, 2013
2 years
February 24, 2011
July 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Health-related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Reference: Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65:571-581.
Week 11
Secondary Outcomes (7)
Health-related quality of life
Week 32
Anxiety and depression
Week 11; week 32
Life satisfaction
Week 11; week 32
Mindfulness
Week 11; week 32
Adaptive coping styles
Week 11; week 32
- +2 more secondary outcomes
Study Arms (1)
Mindfulness-based day-care clinic group program
EXPERIMENTAL11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
Interventions
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
Eligibility Criteria
You may qualify if:
- Diagnosis of cancer
- Physical and mental ability to participate in the program
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276, Germany
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research fellow
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
July 24, 2013
Record last verified: 2013-07