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

URN to cite this document:

urn:nbn:de:bvb:355-epub-330465 Copy

DOI to cite this document:

10.5283/epub.33046 Copy

Klinkhammer-Schalke, Monika ; Lindberg, Patricia ; Koller, Michael ; Wyatt, Jeremy C. ; Hofstädter, Ferdinand ; Lorenz, Wilfried ; Steinger, Brunhilde

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Date of publication of this fulltext: 11 Dec 2015 14:55

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Details

Item type:	Article
Open Access Type:	Gold (with APC)
Journal or Publication Title:	Trials
Publisher:	BMC
Place of Publication:	LONDON
Volume:	16
Number of Issue or Book Chapter:	460
Page Range:	pp. 1-11
Date:	14 October 2015
Institutions:	Medicine > Zentren des Universitätsklinikums Regensburg > Tumorzentrum e.V. Medicine > Institut für Epidemiologie und Präventivmedizin > Tumorzentrum e.V.
Projects (Historical):	Open Access Publizieren (DFG)
Identification Number:	Value Type 10.1186/s13063-015-0972-y DOI
Keywords:	EUROPEAN-ORGANIZATION; HEALTH; COMMUNICATION; ASSESSMENTS; SURVIVAL; OUTCOMES; Quality of life; colorectal cancer; complex intervention; randomised controlled trial; study protocol
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	33046

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Abstract

Background: Medical treatment in patient-centred care in oncology is broadly managed and regulated in terms of guideline development, cancer centres, and quality assurance by cancer registries. In contrast to this quality management cycle (PDCA), there are no equal standards for patient-reported outcomes like quality of life (QoL). Therefore, the Tumour Centre Regensburg e.V., a population-based ...

Abstract

Background: Medical treatment in patient-centred care in oncology is broadly managed and regulated in terms of guideline development, cancer centres, and quality assurance by cancer registries. In contrast to this quality management cycle (PDCA), there are no equal standards for patient-reported outcomes like quality of life (QoL). Therefore, the Tumour Centre Regensburg e.V., a population-based regional cancer registry covering a population of more than 2.2 million people in the Upper Palatinate and Lower Bavaria, Germany, designed and implemented a QoL pathway. In a complex intervention with QoL diagnosis and therapy (multidimensional therapeutic network), effectiveness for patients with breast cancer has been demonstrated. To provide local tailored QoL diagnosis and therapy to other cancer patients as well, external validity needs to be extended by adapting the QoL pathway to another tumour entity. Methods/Design: The QoL pathway will be tested for colorectal cancer patients in a pragmatic randomised controlled trial. Two hundred twenty primary colorectal cancer patients, surgically treated in one of four hospitals, will be included. QoL is measured in all patients 0, 3, 6, 12, and 18 months after surgery (European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-CR29). In the intervention group, QoL scores are transformed into a QoL profile. This is sent to the coordinating practitioner (general practitioner, internist, or oncologist) with an expert report including treatment recommendations for QoL deficits. The control group receives routine follow-up care attending the guideline recommendations for colorectal cancer without profile or expert report. At the primary endpoint (12 months), the rates of patients with diseased QoL in both groups are compared. Discussion: This randomised trial is the first complex intervention investigating the effectiveness of an intervention with QoL diagnosis and tailored QoL therapy in colorectal cancer patients. The results will show if this QoL pathway improves the patients' QoL during follow-up care of their disease.

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Metadata last modified: 20 Jan 2025 14:46

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