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NCT04913259 | Not yet recruiting | Cancer


Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer
Sponsor:

Institut Bergonié

Brief 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.

Condition or disease

Cancer

Intervention/treatment

Remote monitoring

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 33 participants
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Actual Study Start Date : May 25, 2021
Estimated Primary Completion Date : August 25, 2022
Estimated Study Completion Date : May 25, 2023
Arm Intervention/treatment

Other: Remote monitoring for elderly patients with cancer

Other: Remote monitoring

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
  • 5. Patient already included in this study or in another study evaluating a remote monitoring system.

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

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Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

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