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

NCT03959774 | Unknown

• 1 other identifier: E-SN@P PROJECT-IPC 2017-029
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer

Keywords

Elderly population; digital monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

breast or colorectal or lung cancer, age 70 or older

EXPERIMENTAL

breast or colorectal or lung cancer, age 70 or older

Device: IPC NET

Interventions

IPC NET DEVICE

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

breast or colorectal or lung cancer, age 70 or older

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years,
• Patient with an indication of adjuvant chemotherapy showing:
• Breast cancer
• Colorectal cancer
• lung cancer
• \. 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

You may not qualify if:

• 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
• Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
• 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)
• Concurrent participation in another clinical trial
• Patient unable to understand the quality of life survey and Patient Reported Outcome

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (4)

Institut Sainte Catherine

Avignon, France

Location

CHI des Alpes du Sud

Gap, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

CHU Nice

Nice, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Louis Tassy, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 22, 2019
• Study Start: December 30, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)