Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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

Published in: Trials | Issue 1/2015

Login to get access

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.

Trial registration

ClinicalTrials.gov, NCT02321813 (registered December 2014).
Literature
1.
Detmar S, Muller M, Schornagel J, Wever L, Aaronson N. Health-related quality-of-life assessments and patient-physician communication. A randomized controlled trial. JAMA. 2002;288:3027–34.CrossRefPubMed
2.
Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004;22:714–24.CrossRefPubMed
3.
Braeken A, Kempen G, Eekers D, Houben R, van Gils F, Ambergen T, et al. Psychosocial screening effects on health-related outcomes in patients receiving radiotherapy. A cluster randomised controlled trial. Psychooncology. 2013;22:2736–46.CrossRefPubMed
4.
Hollingworth W, Metcalfe C, Mancero S, Harris S, Campbell C, Biddle L, et al. Are needs assessments cost effective in reducing distress among patients with cancer? A randomized controlled trial using the distress thermometer and problem list. J Clin Oncol. 2013;31:3631–8.CrossRefPubMed
5.
Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, et al. 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;393:1–12.CrossRefPubMed
6.
Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, et al. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy approach: randomized trial in 200 women with breast cancer. Br J Cancer. 2012;106:826–38.CrossRefPubMedPubMedCentral
7.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–6.CrossRefPubMedPubMedCentral
8.
Robert Koch-Institut und die Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. Krebs in Deutschland 2007/2008. 8th ed. Berlin: Robert Koch-Institut; 2012
9.
Camilleri-Brennan J, Steele RJC. Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer. Br J Surg. 2001;88:1617–22.CrossRefPubMed
10.
Arndt V, Merx H, Stegmaier C, Ziegler H, Brenner H. Quality of Life in patients with colorectal cancer 1 year after diagnosis compared with the general population: a population-based study. J Clin Oncol. 2004;22:4829–36.CrossRefPubMed
11.
Sprangers MAG, Taal BG, Aaronson NK, te Velde A. Quality of life in colorectal cancer: stoma vs. nonstoma patients. Dis Colon Rectum. 1995;38:361–9.CrossRefPubMed
12.
Camilleri-Brennan J, Steele RJC. Prospective analysis of quality after reversal of a defunctioning loop ileostomy. Colorectal Dis. 2002;4:167–71.CrossRefPubMed
13.
Maisey NR, Norman A, Watson M, Allen MJ, Hill ME, Cunningham D. Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer. 2002;38:1351–7.CrossRefPubMed
14.
Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, et al. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008;17:179–93.CrossRefPubMed
15.
Luckett T, Butow PN, King MT. Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Psychooncology. 2009;18:1129–38.CrossRefPubMed
16.
Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:979–83.CrossRef
17.
Lorenz W, Troidl H, Solomkin SJ, Nies C, Sitter H, Koller M, et al. Second step: testing–outcome measurements. World J Surg. 1999;23:768–80.CrossRefPubMed
18.
19.
Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, et al. Implementing a system of quality of life diagnosis and therapy for breast cancer patients: results of an exploratory trial as prerequisite for a subsequent RCT. Br J Cancer. 2008;99:415–22.CrossRefPubMedPubMedCentral
20.
Rothwell PM. External validity of randomised controlled trials: “To whom do the results of this trial apply?”. Lancet. 2005;365:82–93.CrossRefPubMed
21.
Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. Boston: John Wright–PSG Inc; 1982.
22.
Corporation RAND. A million random digits with 100 000 normal deviates. Glenco III: Free Press; 1955.
23.
Gujral S, Conroy T, Fleissner C, Sezer O, King PM, Avery KNL, et al. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer. 2007;43:1564–73.CrossRefPubMed
24.
Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, et al. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009;45:3017–26.CrossRefPubMed
25.
Fayers P, Aaronson N, Bjordal K, Groenvold M, Curran D, Bottomley A. EORTC QLQ-C30 scoring manual. 3rd ed. Brussels: Bern: EORTC Study Group on Quality of Life; 2001.
26.
27.
Middeke M, Bauhofer A, Kopp I, Koller M. Computerized visualization of quality of life data of individual cancer patients–the QoL-Profiler. Inflamm Res. 2004;53:175–8.CrossRef
28.
Aaronson NK, Ahmdezai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRefPubMed
29.
Hjermstad MJ, Fossa S, Bjordal K, Kaasa S. Test/retest study of the European Organization for Cancer Research and Treatment of Cancer core quality-of-life questionnaire. J Clin Oncol. 1995;13:1249–54.PubMed
30.
Kopp I, Lorenz W, Rothmund M, Koller M. Relation between severe illness and non-completion of quality-of-life questionnaires by patients with rectal cancer. J R Soc Med. 2003;96:442–8.CrossRefPubMedPubMedCentral
31.
Wiens B. A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceut Statist. 2003;2:211–5.CrossRef
32.
Metadata
Title
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
Authors
Monika Klinkhammer-Schalke
Patricia Lindberg
Michael Koller
Jeremy C. Wyatt
Ferdinand Hofstädter
Wilfried Lorenz
Brunhilde Steinger
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0972-y

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Methodology

“I never expected that it would happen, coming to ask me such questions”:Ethical aspects of asking children about violence in resource poor settings

Study protocol

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial

Review

Interventions in randomised controlled trials in surgery: issues to consider during trial design

Study protocol

Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial

Study protocol

SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)

Study protocol

Evaluation of a hospital-based day-structuring exercise programme on exacerbated behavioural and psychological symptoms in dementia - the exercise carrousel: study protocol for a randomised controlled trial