Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients (DIQOL)

September 21, 2017 updated by: Ass. Prof. Dr. Monika Klinkhammer-Schalke, Tumor Center Regensburg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Tumor Center Regensburg e.V., An-Institute of the University of Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: quality of life pathway
Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
Placebo Comparator: control group
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
Other: placebo control
Quality of life measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension)
Time Frame: 1 year after the date of primary surgery for colorectal cancer
1 year after the date of primary surgery for colorectal cancer

Secondary Outcome Measures

Outcome Measure
Time Frame
rates of patients with diseased quality of life in each dimension of the profile
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tumor Center Regensburg

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Chair: Monika Klinkhammer-Schalke, MD, Ass. Prof., Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
  • Principal Investigator: Michael Koller, Ph.D., Prof., Center for Clinical Trials, University Regensburg, Germany
  • Principal Investigator: Wilfried Lorenz, MD, Prof. Ɨ, Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
  • Principal Investigator: Ferdinand Hofstädter, MD, Prof., Johannes Kepler University Linz, Medical Faculty, Austria
  • Principal Investigator: Jeremy C Wyatt, MD, Prof., Leeds Institute of Health Sciences, University of Leeds, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUZ-QL-CRC-14
  • 01GY1339 (Other Grant/Funding Number: German Federal Ministry of Education and Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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