Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer (POSCA)

July 11, 2022 updated by: Cankado GmbH
This is a prospective, single arm, non-interventional project to evaluate the benefit/influence of individualized patient education and guidance with a web-based e-Health platform called CANKADO on patient reported outcomes (PRO) for patients with metastatic colorectal cancer. The focus will be on patient reported outcomes (PRO), distress, Quality of Life (QoL), Global Health Status, complaints and therapy relevant decisions. All patients will be medically treated according to the standards. The experimental arm will include 40 patients. Those patients will receive one initial coaching before start of therapy. Further appointments for coaching will be scheduled depending on individual patient's need. During treatment period the patient is encouraged of joining therapy actively documenting his state of health and occurring health complaints via CANKADO to give the physician a better overview on the process of patient's health behaviour and preparing him for the next doctor-patient consultation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

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
      • Aschaffenburg, Germany, 63739
        • Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg
      • Langen, Germany, 63225
        • Gemeinschaftspraxis für Hämatologie und Onkologie

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with metastatic colorectal cancer in first line treatment treated in "Gemeinschaftspraxis für Hämatologie und Onkologie Langen" or "Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg"

Description

Inclusion Criteria:

  • Minumum age of 18 years
  • Patient with metastatic colorectal cancer

Exclusion Criteria:

-

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of patients' Distress
Time Frame: 6 months
Evaluated using the Screening Tool for Measuring Distress described by the Practice Guidelines in Oncology - v. 1.2005 by the National Comprehensive Cancer Network
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Quality of Life (QoL)
Time Frame: 6 months
Evaluated using the EORTC QLQ-C30, which is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The five functional scales, three symptom scales, one global health status / QoL scale, and six single items are calculated according to the scording procedures defined by the QL Coordinator, Quality of Life Unit, EORTC Data Center.
6 months
Patient's global health status
Time Frame: 6 months
Evaluated using the EQ visual analogue scale (EQ-VAS Scale), a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (maximum value = 100) and 'The worst health you can imagine' (minimum value = 0).
6 months

Collaborators and Investigators

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

Sponsor

Cankado GmbH

Investigators

  • Study Director: Timo Schinköthe, PhD, Cankado GmbH

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 (Actual)

July 11, 2017

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAN-17-02

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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