Clinical trial NCT02321813: Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients
Official title: Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Colorectal Neoplasms
Keywords: quality of life
colorectal cancer
definitive RCT
complex intervention
Lead sponsor: Tumor Center Regensburg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2014-12-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.

Detailed description: There is a growing interest in using quality of life (QoL) data not only as relevant endpoint in clinical trials on cancer patients, but also in routine practice in order to improve patients' health during treatment. The investigators designed, implemented and evaluated an integrated quality of life diagnosis and therapy pathway (QoL pathway) for breast cancer patients (Klinkhammer-Schalke et al, 2008; 2012), guided by the UK Medical Research Council framework for developing and testing complex interventions. It could be demonstrated in a routine setting that breast cancer patients showed a benefit from tailored QoL diagnosis and therapy (Klinkhammer-Schalke et al, 2012).

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

Eligibility criteria: Inclusion Criteria:

* primary colorectal cancer
* 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:

* coordinating practitioner not implemented
* 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

Primary outcomes:
measure: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension)
timeFrame: 1 year after the date of primary surgery for colorectal cancer
Secondary outcomes:
measure: rates of patients with diseased quality of life in each dimension of the profile
timeFrame: 0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Tumor Center Regensburg e.V., An-Institute of the University of Regensburg
state: Bavaria
Study officials:
affiliation: Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
name: Monika Klinkhammer-Schalke, MD, Ass. Prof.
role: STUDY_CHAIR
affiliation: Center for Clinical Trials, University Regensburg, Germany
name: Michael Koller, Ph.D., Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
name: Wilfried Lorenz, MD, Prof. Ɨ
role: PRINCIPAL_INVESTIGATOR
affiliation: Johannes Kepler University Linz, Medical Faculty, Austria
name: Ferdinand Hofstädter, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leeds Institute of Health Sciences, University of Leeds, UK
name: Jeremy C Wyatt, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.