NCT05408195

Brief Summary

The main objective of this pilot study is to evaluate the acceptability of clinical data collection using a semi-automated e-solution based on the use of text messaging among older adults undergoing chemotherapy treatment at home.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

May 24, 2022

Last Update Submit

June 27, 2024

Conditions

Keywords

older adultsnursessmartphoneschemotherapygeriatric oncology.

Outcome Measures

Primary Outcomes (1)

  • Acceptance of semi-automated follow-up

    Proportion of patients who uploaded the application, Proportion of patients who received at least one questionnaire, Proportion of patients who answered at least one questionnaire, Completion questionnaire rate and answered questionnaire rate

    6 months of CHATBOT use

Study Arms (1)

CHATBOT users

EXPERIMENTAL

patients downloading and using the CHATBOT

Device: CHATBOT use

Interventions

Patients benefiting from chemotherapy with outpatient follow-up (conventional follow-up by telephone calls) have the possibility to receive a weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data (completed by the patient and/or their caregivers) on tolerance and compliance to the care plan.

CHATBOT users

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects of 70 years of age or older;
  • Subjects undergoing chemotherapy treatment after a cancer diagnosis;
  • Subjects managed by the oncogeriatrics team at the Toulouse University Hospital as part of an outpatient follow-up and followed by conventional telephone calls and CHATBOT support.

You may not qualify if:

  • Patient's refusal to participate.
  • Patient does not have sufficient equipment for downloading and using the CHATBOT tool
  • Participant under guardianship, curatorship or safeguard of justice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Antoine PIAU, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 7, 2022

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations