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Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer (TS-PAC)

I

Institut Bergonié

Status

Active, not recruiting

Conditions

Cancer

Treatments

Other: Remote monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04913259
IB 2020-03
2020-A02584-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients 65 years of age and over.
  2. Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, 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).

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.

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Remote monitoring for elderly patients with cancer
Other group
Treatment:
Other: Remote monitoring

Trial contacts and locations

1

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Central trial contact

Simone MATHOULIN-PELISSIER, MD, PhD; Mathilde CABART, MD

Data sourced from clinicaltrials.gov

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