NCT07704307

Brief Summary

The WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). Primary outcome is to reduce the risk of deterioration in global quality of life at 6 months during treatment and to prevent the onset of geriatric syndromes.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,010

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

July 9, 2026

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with unchanged or improved global quality of life between M0 and M6.

    6 month

Study Arms (2)

the experimental group, the WARNING pack

EXPERIMENTAL

the WARNING pack + routine care

Other: WARNING Pack

Standard group

NO INTERVENTION

routine care

Interventions

This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form).

the experimental group, the WARNING pack

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged ≥75 years.
  • Patients with confirmed solid cancer or haematological malignancy, regardless of
  • the site of the tumour (single or multiple), - the duration of the disease, or - the treatment modality (adjuvant, neoadjuvant, locally advanced, palliative metastatic).
  • Patients starting a first line of systemic treatment or a new line of treatment after a break of at least six months.
  • Patients treated in a daycare hospital.
  • Persons belonging to or benefiting from a social security scheme.
  • Free and informed consent after receiving appropriate information.

You may not qualify if:

  • Patients under legal protection (guardianship, curatorship).
  • Persons with enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, persons in a health or social care institution, persons under legal protection and patients in emergency situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

January 1, 2031

Last Updated

July 22, 2026

Record last verified: 2026-07