CancerONCO-CHATBOTNCT05408195
E-Care Acceptability for Older People Undergoing Chemotherapy
A study testing CHATBOT use in people with Cancer, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CHATBOT use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- CHATBOT use
- Keywords
- older adults, nurses, smartphones, chemotherapy, geriatric oncology.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHATBOT useDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CHATBOT users | Experimental | patients downloading and using the CHATBOT Receives: Device: CHATBOT use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months of CHATBOT use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Why it stopped: The use of CHATBOT is limited in the service for multiple reasons and nursing resources have been limited for several months, with no prospect of improvement in the months to come.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine PIAU, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408195
- Sponsor's protocol ID
- RC31/19/0517
- Acronym
- ONCO-CHATBOT
- Status last verified
- Jun 2024
- First submitted
- 24 May 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate E-Care Acceptability for Older People Undergoing Chemotherapy at Home
- ClinicalTrials.gov ID
- NCT05408195
- Acronym / sponsor ID
- ONCO-CHATBOT / RC31/19/0517
- Conditions
- Cancer
- Keywords
- older adults, nurses, smartphones, chemotherapy, geriatric oncology.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The use of CHATBOT is limited in the service for multiple reasons and nursing resources have been limited for several months, with no prospect of improvement in the months to come.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHATBOT users | Experimental | Device: CHATBOT usepatients downloading and using the CHATBOT |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHATBOT usePatients 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. | Device | CHATBOT users |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine PIAU, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHATBOT use in people with Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of semi-automated follow-up (time frame: 6 months of CHATBOT use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.