Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 1:23 PM
Study NCT ID:
NCT04913259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TS-PAC
Brief Summary:
Monocentric, prospective cohort pilot study evaluating the feasibility of a online remote monitoring tool during the care of patients over 65 years of age being medically treated for cancer.
Detailed Description:
Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required).
In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.
At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.
In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.
At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A02584-35 | OTHER | ANSM IDRCB number | View |