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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05408195
Other study ID # RC31/19/0517
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2025

Study information

Verified date October 2023
Source University Hospital, Toulouse
Contact Antoine PIAU, MD PhD
Phone 561145669
Email piau.a@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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