CancereRToMSyNCT04915274

Validation of an Electronic Remote Toxicity Management System in Cancer Patients

A study testing uses of an application in people with Cancer, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the psychometric properties (validity, reliability and responsiveness) of the QuestOnco tool, an electronic Remote Toxicity Management System, in adult cancer patients receiving an active anti-cancer treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: uses of an application
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteFrance
Study dates: 18 May 2021to 12 Jan 2022
Phase: Interventional
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

Who may be able to join

Adults (≥18 years);
Written and informed consent;
Diagnosis of solid cancer;
Metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments;
Patient physically/psychologically fit to participate in the study;
Patient able to understand, communicate and use the electronic device;
Patient owning a smartphone or tablet with internet connection;
Treatment supported by the French social security system.

Who cannot join

Unable patient for signing informed consent;
Unable to understand, communicate and use the electronic device;
Patient under trusteeship or guardianship;
Patient under legal or administration protection.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Régional Metz-Thionville
Metz, 57085

Other trials in France

About this study

Official title: Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment

Read the detailed description

In this study, a mobile phone-based remote monitoring system (QuestOnco application) was developed in order to enable the 'real-time' monitoring of patients' symptoms through use of ePROMs. In order to establish if this new application accurately and reliably identifies the anti-cancer treatment related symptoms, its psychometric properties (validity, reliability and responsiveness) have to be assessed.

Hypotheses:

The QuestOnco application will be designed as a promising innovative tool with good psychometric properties in order to detect more rapidly the anti-cancer-related toxicity in adult cancer patients.
The QuestOnco application is an accurate and reliable tool for the identification of the anti-cancer treatment related symptoms as much as current available questionnaires such as PRO-CTCAE and EORTC QLC-QC30 The evaluation of the psychometric properties of the QuestOnco application will be made in two phases. First, the patient's cognitive interviews will allow assessing the content validity of the items. Then focus groups including patients and professional experts will determine the QuestOnco application goals regarding the adverse symptoms management (recommendations provided within the application, connection with General practitioner, medical Oncology team or Emergency departments).

This study will assess the validity, reliability and responsiveness of the QuestOnco in a cohort of patients receiving anti-cancer treatments. The external validity will be directly compared to PRO-CTCAE (Patient-Reported Outcome Common Terminology Criteria for Adverse Events) and to EORTC QLC-QC30 questionnaire.

Conditions: Cancer
Being tested: uses of an application
Keywords: Cancer, Active anticancer drug, Quality of life, QuestOnco application
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

uses of an applicationOther
Patients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity.

Study groups in NCT04915274
Study group	Role	What they receive
Adult cancer patients	Experimental	Patients will be provided with the QuestOnco application for monitoring Receives: Other: uses of an application

What is being measured

The primary outcome is the main question the study is designed to answer.

Convergent validity
PRO-CTCAE The convergent validity will be evaluated by the correlation between the QuestOnco and the weekly paper form of the PRO-CTCAE questionnaire.
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE) External Web Site Policy, the standard lexicon for adverse event reporting in cancer clinical trials.
The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes.
PRO-CTCAE responses are scored from 0 to 4 (minimum/maximum).
Measured: At the end of study completion (Week 6)

Secondary outcomes (7)

Patients' comprehension of QuestOnco application items
Semi-structured cognitive interviews:
Interviews will be conducted to evaluate patients' comprehension of the QuestOnco application items. Items will be modified and restested if more than 2 patients manifest cognitive difficulties. The item modifications will be conducted during focus groups gathering experts including Emergency department practitioners, General practitioner, Oncologists, Pharmacists, and Methodologists. This procedure will be repeated 3 times a maximum for a total of 30 patients.
Measured: At the end of the study completion: Phase I (Day 7)
The known-groups validity assessment
The known-groups validity will be assessed by comparing the QuestOnco items between patients with high and low performance status using the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 vs 2-4 (minimum vs maximum).
Measured: At the end of the study completion (Week 6)
Evaluation of the efficacy of the QuestOnco application in patient care
Calculation of the time spent (minutes) in consultation with the Oncologist using QuestOnco application fill form
Measured: At the end of study completion (Week 6)
Evaluation of the responsiveness of the QuestOnco application in patient care
Calculation of the number (percent) of appointments actually realized using QuestOnco application fill form
Measured: At the end of the study completion (Week 6)
The reliability of the QuestOnco application in patient care
Calculation of the number (percent) of the automatic telephone alert calls to the regional Emergency service using QuestOnco application fill form
Measured: At the end of the study completion (Week 6)
Synchronization of departments (Emergency division, Oncology team) and patients' care
Calculation of the number (percent) of scheduled consultation based on the statement of reported-toxicity score (symptom severity from grades II to IV) of cancer patients using electronic mobile QuestOnco application.
Measured: At the end of the study completion (Week 6)
Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application
The patients' quality of life will be assessed using EORTC QLC-QC30 questionnaire The EORTC QLQ-C30 is a 30-item core-cancer-specific questionnaire-integrating system for assessing the health-related QOL of cancer patients participating in international clinical trials. The questionnaire incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of two items in the global health/QOL scale which use modified 7-point linear analog scales.
Measured: At the end of the study completion (Week 1 and 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202112 Jan 2022

First posted7 Jun 2021
Study start18 May 2021
Primary completion12 Jan 2022
Study completion12 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04915274
Sponsor's protocol ID: 2020-01-CHRMT
Acronym: eRToMSy
Status last verified: Jan 2022
First submitted: 17 May 2021
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Longo R, Goetz C, Campitiello M, Plastino F, Egea J, Legros PO, Elnar AA, Meraihi S, Luporsi E, Noirez V. Content validation of an electronic remote toxicity management system in adult patients undergoing cancer treatment: a prospective longitudinal study on the QuestOnco application. BMC Cancer. 2024 Dec 23;24(1):1568. doi: 10.1186/s12885-024-13312-4.
PubMed 39716103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment
ClinicalTrials.gov ID: NCT04915274
Acronym / sponsor ID: eRToMSy / 2020-01-CHRMT
Conditions: Cancer
Keywords: Cancer, Active anticancer drug, Quality of life, QuestOnco application
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
Study start: 18 May 2021 (actual)
Primary completion: 12 Jan 2022 (actual)
Study completion: 12 Jan 2022 (actual)
First posted: 7 Jun 2021 (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.

Detailed description

Hypotheses:

The QuestOnco application will be designed as a promising innovative tool with good psychometric properties in order to detect more rapidly the anti-cancer-related toxicity in adult cancer patients.
The QuestOnco application is an accurate and reliable tool for the identification of the anti-cancer treatment related symptoms as much as current available questionnaires such as PRO-CTCAE and EORTC QLC-QC30 The evaluation of the psychometric properties of the QuestOnco application will be made in two phases. First, the patient's cognitive interviews will allow assessing the content validity of the items. Then focus groups including patients and professional experts will determine the QuestOnco application goals regarding the adverse symptoms management (recommendations provided within the application, connection with General practitioner, medical Oncology team or Emergency departments).

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adult cancer patients	Experimental	Other: uses of an applicationPatients will be provided with the QuestOnco application for monitoring

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Adults (≥18 years);
Written and informed consent;
Diagnosis of solid cancer;
Metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments;
Patient physically/psychologically fit to participate in the study;

Key exclusion criteria (4 listed)

Unable patient for signing informed consent;
Unable to understand, communicate and use the electronic device;
Patient under trusteeship or guardianship;
Patient under legal or administration protection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
uses of an applicationPatients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity.	Other	Adult cancer patients

Primary outcome

Convergent validity
Time frame: At the end of study completion (Week 6)
PRO-CTCAE The convergent validity will be evaluated by the correlation between the QuestOnco and the weekly paper form of the PRO-CTCAE questionnaire. PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE) External Web Site Policy, the standard lexicon for adverse event reporting in cancer clinical trials. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4 (minimum/maximum).

7 secondary outcomes

Patients' comprehension of QuestOnco application items
Time frame: At the end of the study completion: Phase I (Day 7)
The known-groups validity assessment
Time frame: At the end of the study completion (Week 6)
Evaluation of the efficacy of the QuestOnco application in patient care
Time frame: At the end of study completion (Week 6)
Evaluation of the responsiveness of the QuestOnco application in patient care
Time frame: At the end of the study completion (Week 6)
The reliability of the QuestOnco application in patient care
Time frame: At the end of the study completion (Week 6)
Synchronization of departments (Emergency division, Oncology team) and patients' care
Time frame: At the end of the study completion (Week 6)
Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application
Time frame: At the end of the study completion (Week 1 and 6)

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 24 Jun 2026.
Results publication: PubMed 39716103Longo R, Goetz C, Campitiello M, Plastino F, Egea J, Legros PO, Elnar AA, Meraihi S, Luporsi E, Noirez V. Content validation of an electronic remote toxicity management system in adult patients undergoing cancer treatment: a prospective longitudinal study on the QuestOnco application. BMC Cancer. 2024 Dec 23;24(1):1568. doi: 10.1186/s12885-024-13312-4.
Individual participant dataSharing planned: No

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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.

Raffaele LONGO principal investigator

CHR METZ THIONVILLE

Véronique NOIREZ study director

CHR METZ THIONVILLE

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing uses of an application in people with Cancer, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

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 8 inclusion and 4 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Convergent validity (time frame: At the end of study completion (Week 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04915274, which also lists 1 linked publication.

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 24 Jun 2026.