- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256444
Feasibility Study of a Transition Pathway at Discharge From Full Hospitalization in Oncology (PATROL)
Etude de faisabilité d'un Parcours de Transition à la Sortie d'Hospitalisation complète en Oncologie - Etude Pilote Monocentrique
Patient reported outcomes (PRO) measure the health status directly reported by the patients, without external interpretation, generally collected using self-questionnaires, including online tools (ePRO). This approach is useful in early detection of signs of relapse, with reduced anxiety, improved quality of life and survival, and reduced readmissions to emergency departments in patients with advanced cancer. In the current context where hospitalization is increasingly short, the transition from hospital to home is a critical moment that poses a significant safety challenge Patient follow-up strategies help patients return home, particularly in surgery, with telephone calls from a nurse the day after or several days after discharge. In oncology, telephone calls from the pharmacist 3 days after discharge from hospital helped to identify undesirable effects of treatments. In general medicine, these calls have led to improved patient satisfaction, reduced use of emergency departments and the resolution of drug-related problems, but are costly. The introduction of post-hospitalization ePRO monitoring in oncology could ensure effective follow-up while keeping costs under control. A coordinating nurse could manage this process and play a crucial role in accompanying patients when they return home.
The study authors aimed to evaluate the feasibility of a transitional nurse consultation and ePRO follow-up on discharge from full hospitalization in oncology in this population of frail and elderly patients.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Astrid Basset
- Phone Number: 06.24.89.63.27
- Email: astrid.basset@chu-nimes.fr
Study Locations
-
-
-
Nîmes, France, 30000
- Recruiting
- Centre Hospitalier de Nîmes
-
Sub-Investigator:
- Frédéric Fiteni
-
Contact:
- Anissa Megzari, Doctor
- Phone Number: 04.66.68.42.36
- Email: drc@chu-nimes.fr
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Principal Investigator:
- Astrid Basset
-
Sub-Investigator:
- Pauline Vazquez
-
Sub-Investigator:
- Bruno Beudot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Adult patient hospitalized in an oncology unit for at least 48 hours.
- Patient capable of using a connected device, in possession of a smartphone or tablet, and with an internet connection at home.
- Patient discharged from hospital to go home.
Exclusion Criteria:
- The patient is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient considered to be at the end of life.
- Patient unable to read and understand French
- Patient discharged from hospitalization to a home care facility
- Patient having been hospitalized in a full-time inpatient setting for a scheduled procedure (chemotherapy or interventional procedure)
- Pregnant, parturient, or breastfeeding
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance with ePRO monitoring
Time Frame: Day 2
|
Percentage of patients who responded to all questionnaires
|
Day 2
|
|
Compliance with the telephone call at day 7
Time Frame: Day 7
|
Percentage of patients successfully contacted at day 7
|
Day 7
|
|
Patient satisfaction with the care pathway
Time Frame: Day 15
|
Question: "Are you satisfied with your care pathway?" (Yes/no)
|
Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of the transition pathway to home
Time Frame: Day 15
|
Care Transitions Measure (CTM-3) questionnaire, where a 10-point increase reduces the risk of readmission by 14%
|
Day 15
|
|
Quality of life as reported by the patient
Time Frame: Day 0
|
EORTC QLQ-C30 questionnaire: The score for each subscale ranges from 0 to 100and good quality of life is associated with a high score on the functional scales and a low score on the symptom scales.
|
Day 0
|
|
Quality of life as reported by the patient
Time Frame: Day 7
|
EORTC QLQ-C30 questionnaire: The score for each subscale ranges from 0 to 100and good quality of life is associated with a high score on the functional scales and a low score on the symptom scales.
|
Day 7
|
|
Quality of life as reported by the patient
Time Frame: Day 15
|
EORTC QLQ-C30 questionnaire: The score for each subscale ranges from 0 to 100and good quality of life is associated with a high score on the functional scales and a low score on the symptom scales.
|
Day 15
|
|
Quality of life as reported by the patient
Time Frame: Day 30
|
EORTC QLQ-C30 questionnaire: The score for each subscale ranges from 0 to 100and good quality of life is associated with a high score on the functional scales and a low score on the symptom scales.
|
Day 30
|
|
Patient satisfaction with their care
Time Frame: Day 15
|
EORTC PATSAT-C33 questionnaire: The total score ranges from 0 to 100
|
Day 15
|
|
Rate of readmissions to a healthcare facility
Time Frame: One month after hospitalization
|
Rate of readmissions to healthcare establishments (hospitalization department, emergency room)
|
One month after hospitalization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Astrid Basset, CHU de Nîmes
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2023-2/AB01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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