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

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT04393116
• Lead Sponsor: Cankado GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of patients' Distress	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

Secondary Outcome Measures

Name	Time	Method
Patient's Quality of Life (QoL)	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.
Patient's global health status	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).

Trial Locations

Locations (2)

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie; 🇩🇪 Langen, Germany