Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Phase: NA
Conditions: Cancer
Sponsor: Institut Bergonié

 
   
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REMOTE MONITORING FOR AMBULATORY 
CARE OF ELDERLY PATIENTS WITH CANCER 
 
TS-PAC STUDY 
Protocol version No. 2 – June, 1st 2022 
 
Interventional research protocol involving human participants - 
Category 2 with minimal risks and constraints 
 
N° IB 2020-03 
 
ID-RCB n° 2020-A02584-35 
 
This research is supported by the Interregional South West and Overseas Territories Hospital Group for 
Clinical Research and Innovation (GIRCI SOHO) 
 
Coordinator 
Dr Mathilde CABART, Oncologist  
Medical Oncology Department 
 
Institut Bergonié 
 
229, cours de l’Argonne – 33076 BORDEAUX Cedex 
 
Tel: 05.56.33.19.65 – Fax: 05.56.33.04.85 – Email: m.cabart@bordeaux.unicancer.fr 
 
Research Lead 
Prof Pierre-Louis SOUBEYRAN, Onco-hematologist 
Institut Bergonié 
 
Clinical and Epidemiological Research Unit 
Prof Simone MATHOULIN-PELISSIER, Director  
Institut Bergonié 
Marina PULIDO, Methodologist Statistician 
Institut Bergonié 
Caroline LALET, Clinical studies Manager 
Institut Bergonié 
Carine BELLERA, Biostatistician 
  Institut Bergonié 
Fanny BOUTEILLER, Biostatistician  
 Institut Bergonié 
Ludovic LIEGE, IT technician 
Institut Bergonié 
 
PROMOTOR 
INSTITUT BERGONIÉ 
 
 

 
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SUMMARY 
  
PROMOTOR 
Institut Bergonié 
PRINCIPAL INVESTIGATOR / 
COORDINATOR 
Dr Mathilde CABART  
RESEARCH LEAD 
Prof Pierre-Louis SOUBEYRAN 
ACRONYM 
TS-PAC 
TITLE 
Remote monitoring for ambulatory care of elderly patients with cancer. The 
TS-PAC study 
RATIONALE / CONTEXT 
In France, more than half of patients with cancer are over 65 years old. The 
majority of these elderly patients have geriatric fragilities (Caillet et al., 
2014; Mohile et al., 2011), exposing them to increased risks of toxicity from 
cancer treatments (Extermann et al., 2012; Ruiz et al., 2019), but also to 
undesirable reactions to complications or unscheduled hospitalizations. 
Elderly patients also have different expectations to younger patients 
regarding the goals and consequences of cancer treatments, emphasizing 
the maintenance of quality of life and independence, at the expense of 
quantity of life (Fried et al. al., 2002). 
To provide better care for these patients, it is therefore important to 
diagnose toxicities and treatment complications as early as possible and to 
respond to these better, anticipating possible hospitalizations. Further, 
there is a need to identify tumor events (progression, relapses) early and to 
treat patients before their general condition deteriorates. We must fully 
appreciate the benefits of treatments for patients, not only on tumor 
control but also on quality of life and autonomy. 
Telemedicine and connected health tools seem to be able to improve the 
care of these patients. In the STAR (Basch et al., 2016, 2017) and SENTINEL 
(Denis et al., 2017) studies patients undergoing chemotherapy or having 
completed their treatment received weekly remote monitoring via an online 
questionnaire concerning 12 symptoms. This helped improve quality of life, 
reduce emergency department visits and unscheduled hospitalizations, 
detect tumor progression earlier, start treatment in patients in better 
general condition, and thus lengthened overall survival. 
In addition, patient-reported outcomes (PRO) have been shown to be useful 
to tailor medical management and assess prognosis. PRO collection enables 
better detection of symptoms by the doctor (Detmar et al., 2002; 
Montemurro et al., 2016) and a more accurate estimate of their severity 
(Novello et al., 2014), especially for subjective symptoms (Basch et al., 
2006). This leads to therapeutic adaptations, reduces subsequent 

 
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undesirable effects and improves quality of life. In addition, a patient's 
subjective assessment of his/her quality of life and state of health at the 
start of treatment (for example with the QLQ-C30 questionnaire) is 
correlated with overall survival (Gotay et al., 2008; Lee et al., 2018; Maione 
et al., 2005; Quinten et al., 2009; Sloan et al., 2012). Improvement in or 
deterioration of quality of life during treatment is also correlated with 
survival (Eton et al., 2003; Vickers et al., 2016), probably due to the direct 
effect of treatment on cancer symptoms. However, this is also likely to be 
due to the supportive care that improves both quality of life and overall 
survival (Temel et al., 2010), irrespective of treatment efficacy. 
The TS-PAC study therefore aims to develop a remote monitoring tool 
enabling the weekly collection of symptoms reported by elderly patients 
during cancer treatment, to detect early any toxicities and unfavorable 
changes which might require specific management. This tool will also make 
it possible to collect patient self-reports of perceived benefits observed 
following treatment in addition to the clinical parameters usually assessed 
(e.g. tumor control, progression-free survival and overall survival). 
OBJECTIVES 
Primary objective 
To assess the feasibility of using an online remote monitoring tool during 
the care of patients over the age of 65 who are receiving medical 
treatment for cancer. 
 
Secondary objectives 
• To evaluate and describe the responses to the self-questionnaires 
available on the remote monitoring tool: 
o Number of toxicities and clinical symptoms reported by patients 
triggering a “red” alert. 
o Compliance (for patients on oral therapy). 
o Subjective evaluation of the benefit provided by the treatment. 
o Satisfaction with the use of the remote monitoring tool. 
o Quality of life relative to patient health (EORTC QLQ-C30 and QLQ-
ELD14). 
o Depression and anxiety in patients (HAD scale). 
• To evaluate and describe the other parameters collected by the 
coordinating nurse during telephone and / or clinical follow-up: 
o Risk of drug-related iatrogenesis. 
o Autonomy for activities of daily living using the ADL and IADL scales. 
o Geriatric frailty of patients using the G8 score and, if necessary, an 
onco-geriatric assessment. 
o Precariousness of patients with the EPICES score. 
o Distance and travel time to the care facility. 
o Computer experience. 
o Number of unscheduled hospitalizations and reasons. 
• To describe the feasibility of using the tool at the different evaluation 
points according to patient characteristics at inclusion: 
o Risk of drug-related iatrogenesis. 
o Autonomy for activities of daily living. 
o Geriatric fragility of patients. 
o Precariousness of patients with the EPICES score. 
o Distance and travel time to the care facility. 
o Computer experience. 

 
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• To evaluate technical procedures for the remote monitoring tool. 
• Describe the remote monitoring process (number or rate of alerts by 
level of severity, patient management following alerts triggered by the 
tool, number of telephone reminders made by the Coordinating Nurse to 
the patient). 
ENDPOINTS 
Primary endpoint: 
The primary endpoint is the proportion of patients who completed at least 
all of the following questionnaires at 3 months (9 questionnaires in total): 
• Six weekly questionnaires on toxicities and clinical symptoms 
completed within 3 months of the start of treatment: 
o 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) (Basch et al., 2014; 
National Cancer Institute, 2017). 
o A weekly questionnaire on toxicities and clinical symptoms will 
be considered complete if the patient has answered the first 7 
mandatory questions (out of the 20 items). 
• Two questionnaires assessing the health-related quality of life, 
completed before the start of treatment and at 3 months: 
o Quality of life (QOL) will be assessed using the EORTC QLQ-C30 
questionnaire (Aaronson et al., JNCI 1993) 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. 
o A QOL questionnaire will be considered complete if the scores 
of the 5 functional scales and the overall QOL score are calculable 
(more than 50% of the items of each sub-scale answered) 
according to the EORTC scoring manual. 
• The questionnaire evaluating the perceived benefit of the treatment at 3 
months. The questionnaire will be considered as complete if the patient has 
answered the first question: "How effective do you find your cancer 
treatment?" 
 
Secondary endpoints: 
Answers to the self-questionnaires available on the remote monitoring tool 
• 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. 
• 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. 
• 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. 
• Quality of life will be assessed at inclusion, 3 months and 6 months using 
the EORTC QLQ-C30 questionnaire (Aaronson et al., JNCI 1993) and, for 
people over 70 years old, using the QLQ-ELD14 module specifically for the 
elderly (Wheelwright et al., 2013). The targeted dimensions of the QLQ-C30 

 
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will be the 5 functional scales (physical, daily life, emotional, cognitive, and 
social) and the overall quality of life scale. 
• Depression and anxiety will be assessed at baseline, 3 months and 
6 months, using the HAD questionnaire (Zigmond and Snaith, 1983). 
 
Parameters collected by the Coordinating Nurse during telephone and / or 
clinical follow-up 
At inclusion: 
• The risk of drug-related iatrogenesis will be assessed by collecting the 
number of different drugs taken by the patient (Queneau et al., 2007). 
• Patient autonomy for activities of daily living will be assessed using two 
scales: the ADL scale (Katz et al., 1963) and the IADL scale (Lawton and 
Brody, 1969). 
• The geriatric frailty of patients will be assessed using the G8 score for 
patients aged 70 and over (Soubeyran et al., 2014), and if necessary, using a 
standardized geriatric assessment (EGS). Geriatric interventions will be 
described by domain. Patients will be separated and described according to 
3 groups reflecting their frailty: (1) patients under 70 years old and over 70 
years old with a G8 score> 14, (2) patients over 70 years old with a G8 score 
≤ 14 having had an EGS without intervention, and (3) patients over 70 years 
of age with a G8 score ≤ 14 having had an EGS with geriatric intervention. 
• Patient precariousness will be assessed using the EPICES (Evaluation of 
Deprivation and Inequalities in Health Examination Centres) score (Labbé et 
al., 2007). 
• The distance between the place of residence and facility where the care is 
delivered, as well as the average time required for this journey, will be 
evaluated (collection of the place of residence). 
• Patients' computer experience will be evaluated (regular access to a 
computer, tablet or smartphone, to send emails and / or use applications 
and / or search the Internet). 
At 3 months and 6 months: 
• The number of unscheduled hospitalizations> 24 hours and the number 
of emergency room visits, as well as their reason, will be assessed. 
 
Feasibility of using the tool at different evaluation times depending on the 
characteristics of the patients at inclusion 
The feasibility of using the tool is defined as for the primary endpoint. The 
completion rates of the online questionnaires will be described at 3 
months and 6 months according to the following parameters at inclusion: 
• Risk of drug-related iatrogenesis. 
• Autonomy for activities of daily living. 
• Geriatric frailty of patients. 
• EPICES precariousness score. 
• Distance and travel time to the care facility. 
• Computer experience. 
 
Technical details when using the remote monitoring tool. 
The technical procedures when using the remote monitoring tool will be 
assessed by collecting the following parameters: 
• Type of device on which the application is used (e.g. smartphone, tablet, 
or computer). 
• Number of times the software bugs or crashes 
• Management of the failure by Coordinating Nurse or by the supplier. 
 

 
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Description of the monitoring process 
The remote monitoring process will be described by: 
• The number and / or rate of alerts generated by the tool depending on 
the severity level of the alert. 
• 
The nature and number of actions implemented and interventions 
carried out. 
 
RESEARCH DESIGN 
Single-center, 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. 
INCLUSION CRITERIA 
1. Patients 65 years of age and over. 
2. Histologically proven cancer: breast, lung, ovary, prostate, bladder, 
kidney, ENT, colon-rectum, melanoma, sarcoma, lymphoma, 
myeloma, or myelodysplastic syndrome. 
3. Included before starting medical treatment (chemotherapy, 
hormone 
therapy, 
targeted 
therapy, 
immunotherapy 
or 
combination). 
4. Informed consent dated and signed. 
5. 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). 
NON INCLUSION CRITERIA 
1. Life expectancy less than 12 months. 
2. Patient declining to use a tablet, computer, smartphone 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. 

 
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STUDY PROCEDURE 
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. 
Follow-up by self-questionnaire is as follows: 
•  Weekly: toxicity and clinical symptom assessment questionnaire. 
• Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD 
anxiety and depression assessment questionnaire, questionnaire for the 
subjective assessment of perceived benefit of treatment, and client 
satisfaction with use of the tool questionnaire. 
 
If a "red" alert is triggered, the team will decide on the type of intervention 
which can be: 
• A phone call to the patient 
• A change in treatment 
• Prescription of supportive oncological care 
• A consultation. 
• Hospitalization. 
• The intervention of a local health professional (attending physician, 
nurse). 
• The transmission of potentially useful information to the patient’s 
pharmacist. 
 
Alerts will be raised by the Coordinating Nurse within 24 hours during the 
week, Monday to Friday, 9 a.m. to 5 p.m. excluding public holidays. The 
Nurse will be available and contactable directly if necessary during these 
hours. This is not 24 hour surveillance. Patients will be warned that in an 
emergency, they should systematically contact their attending physician or 
the ambulance (SAMU) outside of these time slots. 
 
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 proceed to the remote 
uninstallation of the application and will organize the return of the 
equipment (tablet and/or 3/4G key) if these were lent for the study.  
SIZE OF STUDY 
The primary endpoint is the proportion of patients who completed at least 
9 questionnaires at 3 months: 6 weekly toxicities / clinical symptoms 
questionnaires (20 items including 7 mandatory) + 2 EORTC QLQ-C30 quality 
of life questionnaires (30 items, mandatory scores for the 5 functional scales 
+ the overall QOL) + 1 questionnaire evaluating the benefit of the treatment 
perceived by the patient (3 items, 1st question mandatory). 
 
Based on the results of other feasibility studies on remote monitoring in 
oncology (SENTINEL (Denis et al., 2014), STAR (Judson et al., 2013) and e-
DomSanté1 (Quénel-Tueux et al., 2018)), we will consider the use of our 
online tool for the remote monitoring of elderly patients with cancer as 
feasible if 75% of the patients included and having started medical 

 
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treatment against cancer answer all the questionnaires defined in the 
primary endpoint criterion. The inclusion of 30 eligible and evaluable 
patients will allow us to estimate this rate of 75% of patients who answered 
all the questionnaires (9 in total) with a 95% confidence interval on a 
bilateral basis of (55.6% - 88.2%). The confidence interval was calculated 
using Wilson's method with continuity correction. Estimating that 10% of 
patients will not be eligible / evaluable, we estimate that 33 patients should 
be included. 
RESEARCH DURATION 
Duration of the inclusion period: 24 months 
Duration of participation of each participant: 6 months 
Total duration of research: 30 months 
STATISTICAL ANALYSIS 
Analysis populations 
• Eligible population: all patients included with no major deviations from 
the eligibility criteria. 
• Eligible and assessable population: eligible patients who started medical 
treatment (chemotherapy, hormone therapy, targeted therapy, 
immunotherapy or combination). 
 
Statistical analyses: 
• The primary endpoint will be calculated from the eligible and assessable 
population. 
• The proportion of patients who completed 9 questionnaires at three 
months will be calculated as follows: number of eligible and assessable 
patients who completed the 9 questionnaires at 3 months divided by the 
number of eligible and assessable patients. The proportion will be reported 
with its 95% confidence interval (binomial law). 
• The secondary endpoints will be calculated from the eligible and 
assessable population as for the primary endpoint. 
• The scores of the questionnaires (continuous variables) will be described 
on the basis of means (+/- standard deviation) if the normality hypothesis 
is satisfied, and failing that, on the basis of other descriptive statistics 
(median, range, quartiles). 
• The scores can be categorized according to the thresholds described in 
the literature. For each questionnaire, the proportion of patients with a 
score above or below the predefined threshold will then be reported with 
its 95% confidence interval (binomial law). 
• The quantitative variables will be described from the mean and the 
standard deviation if the assumption of normality is respected, failing 
other descriptive statistics will be used (minimum, maximum, median and 
quartiles). 
• The qualitative variables will be described on the basis of the numbers 
and associated frequencies, expressed as a percentage (%). 
For each variable, the number of missing data will be described. Whenever 
possible, the reasons will be documented to assist the interpretation of 
results. 

 
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EXPECTED OUTCOMES 
To assess the feasibility of using an online tool for elderly patients. 
Improve the coordination of care between hospital and home health 
professionals. 
Create a new strategy for monitoring patients undergoing treatment for 
cancer, to optimize their care pathway, and to reduce health inequalities 
that may affect elderly patients at risk due to their geriatric fragility. 
Introduce patient-reported outcomes into standard care which will thus be 
more centered around the patient, empowering the patient. PRO collected 
from elderly patients can also be used routinely, to educate caregivers to 
take into account the most frequent symptoms, but also in future 
therapeutic trials on elderly cancer patients.