E-Care Acceptability for Older People Undergoing Chemotherapy (ONCO-CHATBOT)

June 27, 2024 updated by: University Hospital, Toulouse

Evaluate E-Care Acceptability for Older People Undergoing Chemotherapy at Home

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Most cancer diagnosis are made among the 70 years and over population. In this population, negative consequences of cancer treatments are of great concern, especially for those who are socially isolated or live in rural areas. International oncology societies recommend personalized treatments to reduce adverse events. However, few tools have been validated in this population to monitor compliance and risks of outpatient treatments. In addition, health professionals continue to manage unplanned patient calls which could disrupt effectiveness of their work. Our hypothesis is that the semi-automated collection of health data (text message questionnaires) during outpatient chemotherapy secures the patient's care pathway and optimizes care time, in particular for patients' education and support. Therefore, patients (and/or their caregivers) who benefit from calls follow-up (usual care), would have the possibility of receiving an additional weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data on tolerance and compliance with care plan.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHATBOT users
patients downloading and using the CHATBOT
Device: CHATBOT use
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of semi-automated follow-up
Time Frame: 6 months of CHATBOT use
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Antoine PIAU, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/19/0517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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