NCT04393116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

4.4 years

First QC Date

May 6, 2020

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Development of patients' Distress

    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 Outcomes (2)

  • Patient's Quality of Life (QoL)

    6 months

  • Patient's global health status

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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"

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, 63225, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Timo Schinköthe, PhD

    Cankado GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 19, 2020

Study Start

July 11, 2017

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations