Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients
NCT ID: NCT02321813
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2014-01-31
2017-06-30
Brief Summary
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Detailed Description
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But there is also requirement for managing QoL deficits of patients with other cancers and to replicate findings of the previous trial. To achieve this aim, the QoL pathway has been modified for colorectal cancer patients. The Tumor Center Regensburg provides the infrastructure of the present project (quality circles, project groups).
This is a two-arm randomised clinical trial with one intervention group and one control group. Patients' QoL is assessed with the EORTC QLQ-C30 and QLQ-CR29 at 0, 3, 6, 12, and 18 months after surgery.
In intervention group results of the QoL-measure are transferred to a QoL-profile including 13 dimensions on scales of 0-100 (cutoff for "diseased QoL \<50). Three experts with varying professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option have been founded. Coordinating practitioners receive a list with addresses of all quality circle members.
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
The investigators expect that patients in the intervention group will experience a lower number of QoL-deficits (QoL \< 50 points) in the first year after surgery compared with patients in the control group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intervention group
In the quality of life pathway results of the quality of life (QoL) measure are transferred to a QoL-profile. Three experts with various professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option haven been founded. Coordinating practitioners receive a list with addresses of all quality circle members.
quality of life pathway
Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
control group
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
placebo control
Quality of life measurement
Interventions
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quality of life pathway
Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
placebo control
Quality of life measurement
Eligibility Criteria
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Inclusion Criteria
* operated in one of four participating certified cancer centres for colorectal cancer (Krankenhaus Barmherzige Brüder, Department of Surgery, Regensburg; Germany; Caritas-Krankenhaus St. Josef, Department of Surgery, Regensburg; Germany; Klinikum Neumarkt., Department of Surgery, Neumarkt; Germany; Klinikum St. Elisabeth Straubing, Department of Surgery, Straubing, Germany), documented in a population-based cancer registry (Tumor Center Regensburg e.V.)
* informed consent.
Exclusion Criteria
* patient from district outside the study region (rural districts Regensburg, Neumarkt, Straubing, Straubing-Bogen, Kelheim, Schwandorf)
* patient unable to fill out the questionnaire for physical, psychological or language reasons (including dementia)
* age under 18 years
* pregnancy
* QoL clinician unavailable
* refusal to participate
18 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Tumor Center Regensburg
OTHER
Responsible Party
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Ass. Prof. Dr. Monika Klinkhammer-Schalke
PD Dr.med. Monika Klinkhammer-Schalke
Principal Investigators
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Monika Klinkhammer-Schalke, MD, Ass. Prof.
Role: STUDY_CHAIR
Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
Michael Koller, Ph.D., Prof.
Role: PRINCIPAL_INVESTIGATOR
Center for Clinical Trials, University Regensburg, Germany
Wilfried Lorenz, MD, Prof. Ɨ
Role: PRINCIPAL_INVESTIGATOR
Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
Ferdinand Hofstädter, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Johannes Kepler University Linz, Medical Faculty, Austria
Jeremy C Wyatt, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Leeds Institute of Health Sciences, University of Leeds, UK
Locations
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Tumor Center Regensburg e.V., An-Institute of the University of Regensburg
Regensburg, Bavaria, Germany
Countries
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References
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Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012 Feb 28;106(5):826-38. doi: 10.1038/bjc.2012.4. Epub 2012 Feb 7.
Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer. 2008 Aug 5;99(3):415-22. doi: 10.1038/sj.bjc.6604505.
Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstadter F, Lorenz W. Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg. 2008 Jan;393(1):1-12. doi: 10.1007/s00423-007-0210-5. Epub 2007 Jul 28.
Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13.
Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstadter F, Lorenz W, Steinger B. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:460. doi: 10.1186/s13063-015-0972-y.
Other Identifiers
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01GY1339
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TUZ-QL-CRC-14
Identifier Type: -
Identifier Source: org_study_id