Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

Breast Cancer Clinical Trial

— E-SN@P PROJECT  

Official title:

Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03959774
• Other study ID #: E-SN@P PROJECT-IPC 2017-029
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

adherence of digital follow-up in a population of elderly patients.

Description:

The use of digital self-questionnaires adapted to elderly patients but also to BrC and Bac could detect the toxicities of chemotherapy and we formulate the hypothesis that the continuous monitoring of these different variables in elderly patients treated with chemotherapy is possible and acceptable to this population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 119
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Age = 70 years,

2. Patient with an indication of adjuvant chemotherapy showing:

• Breast cancer

• Colorectal cancer

• lung cancer

4. WHO = 3 (WHO index - World Health Organization) 5. Estimated life expectancy> 6 months

6. patients with a smartphone or tablet with an internet connection. It can also be offered to patients whose primary caregiver or the person of trust (including the partner) has a smartphone, an internet connection or a tablet provided that he or she is present more than three times during the week. during chemotherapy to ensure smooth weekly data transfer and filling of questionnaires 7. Signed consent to participation 8. Affiliation to, or beneficiary of, a social security scheme

Exclusion Criteria:

1. Person in emergency situation, person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his / her consent

2. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons

3. Contraindications to the procedure of the study: patient or caregiver living with a patient who does not have a smartphone with an internet connection (patient or caregiver living with a patient)

4. Concurrent participation in another clinical trial

5. Patient unable to understand the quality of life survey and Patient Reported Outcome

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer

Intervention

Device:
• IPC NET
a digital pack with connected bracelet and connected balance will be given to the patient. IPC NET and Nokia Health applications will be downloaded. Pairing between connected objects and the smartphone will be done during the inclusion visit

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	CHI des Alpes du Sud	Gap
France	Institut Paoli-Calmettes	Marseille
France	CHU Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.	numerical follow-up compliance rate, defined as the rate of patients who observed the following three rules during the entire course of adjuvant chemotherapy: a minimum weight per week, the wearing of the bracelet for three consecutive days per week, and the weekly response to the digital self-questionnaire. Failure to comply with at least one of these rules will be considered a failure.	12 months after the last chemotherapy received by the patient