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Completed

NCT Number: NCT01303822

Mindfulness-based Stress Reduction in Cancer Treatment

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine

Essen, North Rhine-Westphalia, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

Mindfulness-based day-care clinic group program

Behavioral

11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.

Primary outcomes

  1. Health-related quality of life

    Time frame: Week 11

    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 outcomes

  1. Health-related quality of life

    Time frame: Week 32

    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.

  2. Anxiety and depression

    Time frame: Week 11; week 32

    Hospital Anxiety and Depression Score (HADS)

  3. Life satisfaction

    Time frame: Week 11; week 32

    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.

  4. Mindfulness

    Time frame: Week 11; week 32

    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.

  5. Adaptive coping styles

    Time frame: Week 11; week 32

    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.

  6. Spiritual and religious attitudes in dealing with illness

    Time frame: Week 11; week 32

    SpREUK questionnaire.

    Reference: Büssing A. Spirituality as a resource to rely on in chronic illness: the SpREUK questionnaire. Religions 2010;1:9-17.

  7. Interpretation of illness

    Time frame: Week 11; week 32

    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.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study 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)

Acronym: SASO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2011
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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