NCT07256444

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

November 20, 2025

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Compliance with ePRO monitoring

    Percentage of patients who responded to all questionnaires

    Day 2

  • Compliance with the telephone call at day 7

    Percentage of patients successfully contacted at day 7

    Day 7

  • Patient satisfaction with the care pathway

    Question: "Are you satisfied with your care pathway?" (Yes/no)

    Day 15

Secondary Outcomes (7)

  • Quality of the transition pathway to home

    Day 15

  • Quality of life as reported by the patient

    Day 0

  • Quality of life as reported by the patient

    Day 7

  • Quality of life as reported by the patient

    Day 15

  • Quality of life as reported by the patient

    Day 30

  • +2 more secondary outcomes

Interventions

Interview with the coordinating nurse who reviews the patient's prescriptions and appointments, installs the electronic patient-reported outcome (ePRO) application on the patient's smartphone and explains collection of any symptoms. ePRO symptom monitoring by the patient on D2, D7 and D15 after discharge. The coordinating nurse phones the patient on D7 to review the symptoms reported, assess compliance with treatment and provide support. In the event of grade ≥ 2 symptoms, the nurse contacts the patient for further information and informs the referring oncologist, who decides on the course of treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients treated as inpatients in the Medical Oncology Department of Nîmes University Hospital and scheduled to be discharged and returned home.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Nimes

Nîmes, 30000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Astrid Basset

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations