CancerOncoPREMsNCT06356363
Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs)
An observational study of Cancer, run by Institut Jean-Godinot.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Data collection
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Nov 2025
- 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: Patient with cancer regardless of location or stage.
Who may be able to join
- cancer patient
- regardless of location or stage
- Fluent in French
- aged more than 18 years old
- Agreeing to take part in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Data collection
- Keywords
- Oncology, oncology care pathway, patients' perception, questionnaire, psychometric validation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| Cancer patient | Patient with cancer regardless of location or stage. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation
Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne
- Responsible party
- Sponsor
- Investigators
- DIOURI Loubna, Principal investigator, Institut Godinot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356363
- Sponsor's protocol ID
- 2023_RIPH_005_OncoPREMs
- Acronym
- OncoPREMs
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway
- ClinicalTrials.gov ID
- NCT06356363
- Acronym / sponsor ID
- OncoPREMs / 2023_RIPH_005_OncoPREMs
- Conditions
- Cancer
- Keywords
- Oncology, oncology care pathway, patients' perception, questionnaire, psychometric validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patient | – | Other: Data collectionPatient with cancer regardless of location or stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cancer regardless of location or stage.
Key inclusion criteria (5 listed)
- cancer patient
- regardless of location or stage
- Fluent in French
- aged more than 18 years old
- Agreeing to take part in the study
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Data collectiondata collection | Other | Cancer patient |
Primary outcome
Psychometric validation
Time frame: Day 0
Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
DIOURI Loubna principal investigator
Institut Godinot
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Jean-Godinot.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (0326918822 ext. +33, coralie.barbe1@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric validation (time frame: Day 0). 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 10 Apr 2024.