- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02321813
Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients (DIQOL)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Bavaria
-
Regensburg, Bavaria, Tyskland, 93053
- Tumor Center Regensburg e.V., An-Institute of the University of Regensburg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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 measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
|
Placebo-jämförare: control group
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
|
Quality of life measurement
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension)
Tidsram: 1 year after the date of primary surgery for colorectal cancer
|
1 year after the date of primary surgery for colorectal cancer
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
rates of patients with diseased quality of life in each dimension of the profile
Tidsram: 0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer
|
0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Monika Klinkhammer-Schalke, MD, Ass. Prof., Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
- Huvudutredare: Michael Koller, Ph.D., Prof., Center for Clinical Trials, University Regensburg, Germany
- Huvudutredare: Wilfried Lorenz, MD, Prof. Ɨ, Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
- Huvudutredare: Ferdinand Hofstädter, MD, Prof., Johannes Kepler University Linz, Medical Faculty, Austria
- Huvudutredare: Jeremy C Wyatt, MD, Prof., Leeds Institute of Health Sciences, University of Leeds, UK
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TUZ-QL-CRC-14
- 01GY1339 (Annat bidrag/finansieringsnummer: German Federal Ministry of Education and Research)
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