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NCT Number: NCT04913259

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonie

Bordeaux, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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.

  • Patient already included in this study or in another study evaluating a remote monitoring system.

Treatment and study plan

Remote monitoring

Other

Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.

    Time frame: Weekly during 6 months

    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.

  2. Rate of Patients With Perceived Benefit of Treatment.

    Time frame: 3 months and 6 months

    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.

  3. Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool

    Time frame: 3 months and 6 months

    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.

  4. Quality of Life (EORTC QLQ-C30)

    Time frame: 3 months and 6 months

    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.

  5. Depression and Anxiety Using the HAD Questionnaire

    Time frame: 3 months and 6 months

    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.

  6. Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits

    Time frame: 6-month follow-up

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study

Acronym: TS-PAC

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jun 4, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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