Metastatic Colorectal CancerPOSCANCT04393116
Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Cankado GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 11 Jul 2017to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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"
Who may be able to join
- Minumum age of 18 years
- Patient with metastatic colorectal cancer
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg
Aschaffenburg, 63739
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, 63225
About this study
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.
- Conditions
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Patient's Quality of Life (QoL)
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.
Measured: 6 months
Patient's global health status
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start11 Jul 2017
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cankado GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timo Schinköthe, PhD, Study director, Cankado GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393116
- Sponsor's protocol ID
- CAN-17-02
- Acronym
- POSCA
- Status last verified
- Jul 2022
- First submitted
- 6 May 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04393116
- Acronym / sponsor ID
- POSCA / CAN-17-02
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cankado GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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"
Key inclusion criteria (2 listed)
- Minumum age of 18 years
- Patient with metastatic colorectal cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Patient's Quality of Life (QoL)
Time frame: 6 months
Patient's global health status
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Schinköthe, PhD study director
Cankado GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Cankado GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of patients' Distress (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.