Mindfulness-based Stress Reduction in Cancer Treatment (SASO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01303822
First received: February 24, 2011
Last updated: July 23, 2013
Last verified: July 2013
  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)

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 117
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: March 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303822

Locations
Germany
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, Northrhine-Westphalia, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
  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: July 23, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on October 23, 2014