Validation of an Electronic Remote Toxicity Management System in Cancer Patients

NCT04915274 | Completed DMC

• 1 other identifier: 2020-01-CHRMT
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Cancer; Active anticancer drug; Quality of life; QuestOnco application

Outcome Measures

Primary Outcomes (1)

• 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).

  At the end of study completion (Week 6)

Secondary Outcomes (7)

• Patients' comprehension of QuestOnco application items

  At the end of the study completion: Phase I (Day 7)

• The known-groups validity assessment

  At the end of the study completion (Week 6)

• Evaluation of the efficacy of the QuestOnco application in patient care

  At the end of study completion (Week 6)

• Evaluation of the responsiveness of the QuestOnco application in patient care

  At the end of the study completion (Week 6)

• The reliability of the QuestOnco application in patient care

  At the end of the study completion (Week 6)

Study Arms (1)

Adult cancer patients

EXPERIMENTAL

Patients will be provided with the QuestOnco application for monitoring

Other: uses of an application

Interventions

uses of an application OTHER

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

Adult cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

Centre Régional Metz-Thionville

Metz, 57085, France

Location

Related Publications (1)

• 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.

  PMID: 39716103 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Raffaele LONGO

  CHR METZ THIONVILLE

  PRINCIPAL INVESTIGATOR

• Véronique NOIREZ

  CHR METZ THIONVILLE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 7, 2021
• Study Start: May 18, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)