Mindfulness-based Stress Reduction in Cancer Treatment

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Mindfulness-based day-care clinic group program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer Physical and mental ability to participate in the program Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based day-care clinic group program<br>11 weeks of mindfulness-based day-care clinic group program. 6 hours per week. | Behavioral: Mindfulness-based day-care clinic group program<br>* 11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 32 | 
| Anxiety and depression | Hospital Anxiety and Depression Score (HADS) | Week 11; week 32 | 
| Life satisfaction | 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. | Week 11; week 32 | 
| Mindfulness | 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. | Week 11; week 32 | 
| Adaptive coping styles | 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. | Week 11; week 32 | 
| Spiritual and religious attitudes in dealing with illness | SpREUK questionnaire. Reference: Büssing A. Spirituality as a resource to rely on in chronic illness: the SpREUK questionnaire. Religions 2010;1:9-17. | Week 11; week 32 | 
| Interpretation of illness | 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. | Week 11; week 32 |