Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs) (OncoPREMs)

April 4, 2024 updated by: Institut Jean-Godinot

Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway

Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.

PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.

In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aims of the study are to constitute a questionnaire to assess patients' perceptions of their oncology care pathway and to perform its psychometric validation.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with cancer regardless of location or stage.

Description

Inclusion Criteria:

  • cancer patient
  • regardless of location or stage
  • Fluent in French
  • aged more than 18 years old
  • Agreeing to take part in the study

Exclusion Criteria:

  • With an estimated life expectancy of less than 3 months
  • In remission, untreated or without follow-up for more than 12 months
  • Protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patient
Patient with cancer regardless of location or stage.
Other: Data collection
data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric validation
Time Frame: Day 0
Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Jean-Godinot

Collaborators

Université de Reims Champagne-Ardenne

Investigators

  • Principal Investigator: DIOURI Loubna, Institut Godinot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_RIPH_005_OncoPREMs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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