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Completed

NCT Number: NCT04393116

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Cankado GmbH

Industry

Registry information

Acronym: POSCA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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