Mindfulness-based Stress Reduction in Cancer Treatment

Neoplasms Clinical Trial

— SASO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303822
• Other study ID #: 11-4600
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: July 23, 2013
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cancer

• Physical and mental ability to participate in the program

Exclusion Criteria:

• Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine	Essen	Northrhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Anxiety and depression	Hospital Anxiety and Depression Score (HADS)	Week 11; week 32	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No