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Mindfulness-based Stress Reduction in Cancer Treatment (SASO)

This study is currently recruiting participants.
Verified October 2012 by Universität Duisburg-Essen
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01303822
First received: February 24, 2011
Last updated: October 26, 2012
Last verified: October 2012
History of Changes

February 24, 2011
October 26, 2012
March 2011
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01303822 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Mindfulness-based Stress Reduction in Cancer Treatment
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)

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Behavioral: Mindfulness-based day-care clinic group program
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
Experimental: Mindfulness-based day-care clinic group program
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
Intervention: Behavioral: Mindfulness-based day-care clinic group program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of cancer
  • Physical and mental ability to participate in the program

Exclusion Criteria:

  • Pregnancy
Both
18 Years and older
No
Contact: Holger Cramer, Dipl-Psych +49(201)174 25054 h.cramer@kliniken-essen-mitte.de
Germany
 
NCT01303822
11-4600
No
Holger Cramer, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Not Provided
Universität Duisburg-Essen
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP