CancerTS-PACNCT04913259
Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer
A study testing Remote monitoring in people with Cancer, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years of age and over.
- Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
- Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
- Informed consent dated and signed.
- Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health).
Who cannot join
- Life expectancy less than 12 months. 2. Patient declining to use a tablet, computer, mobile phone or the Internet. 3. Patient not knowing how to read and understand French. 4. Technical impossibility of connecting to the Internet in the patient's living area.
- 5. Patient already included in this study or in another study evaluating a remote monitoring system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Remote monitoring
- Keywords
- Remote monitoring, Elderly patients, Cancer, Ambulatory care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoringOther
Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring for elderly patients with cancer | Other | Not described Receives: Other: Remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total):
- 6 weekly questionnaires on toxicities and clinical symptoms completed within 3 months of the start of treatment: Toxicities and clinical symptoms will be assessed through 20 questions selected and adapted from the French version of the PRO (patient-reported outcomes) of the CTCAE (Common Terminology Criteria for Adverse Events);
- 2 questionnaires assessing the health-related quality of life, completed before the start of treatment and at 3 months: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire comprising 30 items. The targeted dimensions of the QLQ-C30 will be the five functional scales (physical, daily activity, emotional, cognitive and social) and the overall quality of life scale;
- The questionnaire evaluating the perceived benefit of the treatment at 3 months.
Measured: 3 months
Secondary outcomes (6)
Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.
Toxicities and symptoms will be assessed weekly using 20 questions selected and adapted from the French version of the CTCAE PRO (Basch et al., 2014; National Cancer Institute, 2017). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required). The number of red alerts will be collected for each patient.
Measured: Weekly during 6 months
Rate of Patients With Perceived Benefit of Treatment.
The subjective evaluation of the perceived benefit of treatment will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. The proportion of patients will be reported for each item of the questionnaire.
Measured: 3 months and 6 months
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool
Patient satisfaction with the use of the remote monitoring tool will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. The rate will be reported for each item.
Measured: 3 months and 6 months
Quality of Life (EORTC QLQ-C30)
Quality of life will be assessed at inclusion, 3 months and 6 months using the EORTC QLQ-C30 questionnaire (Aaronson et al., JNCI 1993). The targeted dimensions of the QLQ-C30 will be the 5 functional scales (physical, daily life, emotional, cognitive, and social) and the overall quality of life scale. Standardized scores are presented (range : 0-100). A higher score indicates a better functioning and quality of life.
Measured: 3 months and 6 months
Depression and Anxiety Using the HAD Questionnaire
Depression and anxiety will be assessed at 3 months and 6 months, using the HAD questionnaire (Zigmond and Snaith, 1983). This questionnaire comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), thus yielding two scores (maximum score for each = 21). A higher score indicates greater anxiety or depression.
Measured: 3 months and 6 months
Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Jun 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde CABART, Dr, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913259
- Sponsor's protocol ID
- IB 2020-03
- Other IDs
- 2020-A02584-35
- Acronym
- TS-PAC
- Status last verified
- Sep 2026
- First submitted
- 20 May 2021
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
- ClinicalTrials.gov ID
- NCT04913259
- Acronym / sponsor ID
- TS-PAC / IB 2020-03
- Conditions
- Cancer
- Keywords
- Remote monitoring, Elderly patients, Cancer, Ambulatory care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring for elderly patients with cancer | Other | Other: Remote monitoring |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients 65 years of age and over.
- Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
- Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
- Informed consent dated and signed.
- Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health).
Key exclusion criteria (2 listed)
- Life expectancy less than 12 months. 2. Patient declining to use a tablet, computer, mobile phone or the Internet. 3. Patient not knowing how to read and understand French. 4. Technical impossibility of connecting to the Internet in the patient's living area.
- 5. Patient already included in this study or in another study evaluating a remote monitoring system.
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 |
|---|---|---|
| Remote monitoringOnline remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer | Other | Remote monitoring for elderly patients with cancer |
Primary outcome
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
Time frame: 3 months
The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total): * 6 weekly questionnaires on toxicities and clinical symptoms completed within 3 months of the start of treatment: Toxicities and clinical symptoms will be assessed through 20 questions selected and adapted from the French version of the PRO (patient-reported outcomes) of the CTCAE (Common Terminology Criteria for Adverse Events); * 2 questionnaires assessing the health-related quality of life, completed before the start of treatment and at 3 months: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire comprising 30 items. The targeted dimensions of the QLQ-C30 will be the five functional scales (physical, daily activity, emotional, cognitive and social) and the overall quality of life scale; * The questionnaire evaluating the perceived benefit of the treatment at 3 months.
6 secondary outcomes
Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.
Time frame: Weekly during 6 months
Rate of Patients With Perceived Benefit of Treatment.
Time frame: 3 months and 6 months
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool
Time frame: 3 months and 6 months
Quality of Life (EORTC QLQ-C30)
Time frame: 3 months and 6 months
Depression and Anxiety Using the HAD Questionnaire
Time frame: 3 months and 6 months
Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits
Time frame: 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mathilde CABART, Dr principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote monitoring in people with Cancer, run by Institut Bergonié 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months (time frame: 3 months). 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 8 Oct 2026.