Mindfulness-based Stress Reduction in Cancer Treatment (SASO)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasms |
Behavioral: Mindfulness-based day-care clinic group program |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mindfulness-based Stress Reduction in Supportive Cancer Treatment: Effects of a Day-care Clinic Group Program on Psychometric Parameters in Cancer Patients (Stressbewältigung Durch Achtsamkeit in Der Supportiven Onkologischen Therapie (SASO): Auswirkung Eines Tagesklinischen Gruppenprogramms Auf Psychometrische Parameter Bei Krebspatienten) |
- Health-related quality of life [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
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.
- Health-related quality of life [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
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.
- Anxiety and depression [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]Hospital Anxiety and Depression Score (HADS)
- Life satisfaction [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]
Brief Multidimensional Life Satisfaction Scale (BMLSS).
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
- Mindfulness [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]Freiburg Mindfulness Inventory (FMI). Reference:Walach H, Buchheld N, Buttenmüller V, Kleinknecht N, Grossmann P, Schmidt S (2003). Empirische Erfassung der Achtsamkeit - Die Konstruktion des Freiburger Fragebogen zur Achtsamkeit (FFA) und weitere Validierungsstudien. In Heidenreich T, Michalak J: Achtsamkeit und Akzeptanz in der Psychotherapie, dgvt-Verlag.
- Adaptive coping styles [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]
AKU questionnaire.
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
- Spiritual and religious attitudes in dealing with illness [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]
SpREUK questionnaire.
Reference: Büssing A. Spirituality as a resource to rely on in chronic illness: the SpREUK questionnaire. Religions 2010;1:9-17.
- Interpretation of illness [ Time Frame: Week 11; week 32 ] [ Designated as safety issue: No ]
Interpretation of Illness Questionnaires (IIQ).
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mindfulness-based day-care clinic group program
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
|
Behavioral: Mindfulness-based day-care clinic group program
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of cancer
- Physical and mental ability to participate in the program
Exclusion Criteria:
- Pregnancy
Contacts and Locations| Contact: Holger Cramer, Dipl-Psych | +49(201)174 25054 | h.cramer@kliniken-essen-mitte.de |
| Germany | |
| Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine | Recruiting |
| Essen, Northrhine-Westphalia, Germany, 45276 | |
| Contact: Holger Cramer, Dipl.-Psych +49(201)174 25054 h.cramer@kliniken-essen-mitte.de | |
More Information
No publications provided
| Responsible Party: | Holger Cramer, Research fellow, Universität Duisburg-Essen |
| ClinicalTrials.gov Identifier: | NCT01303822 History of Changes |
| Other Study ID Numbers: | 11-4600 |
| Study First Received: | February 24, 2011 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013