NCT01303822

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

February 24, 2011

Last Update Submit

July 23, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Health-related quality of life

    Week 32

  • Anxiety and depression

    Week 11; week 32

  • Life satisfaction

    Week 11; week 32

  • Mindfulness

    Week 11; week 32

  • Adaptive coping styles

    Week 11; week 32

  • +2 more secondary outcomes

Study Arms (1)

Mindfulness-based day-care clinic group program

EXPERIMENTAL

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

Behavioral: Mindfulness-based day-care clinic group program

Interventions

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

Mindfulness-based day-care clinic group program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations