Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment (E-SN@P PROJECT)

July 27, 2020 updated by: Institut Paoli-Calmettes
adherence of digital follow-up in a population of elderly patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France
        • Institut Sainte Catherine
        • Contact:
          • Sylvie Kircher
        • Principal Investigator:
          • Sylvie Kircher, Dr
      • Gap, France
        • Chi Des Alpes Du Sud
        • Contact:
          • Olivier Guillem
        • Principal Investigator:
          • Olivier Guillem
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
        • Principal Investigator:
          • Louis Tassy, MD
      • Nice, France
        • CHU Nice
        • Contact:
          • Rabia Bouhalassass, MD
        • Principal Investigator:
          • Rabia Bouhalassass

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: breast or colorectal or lung cancer, age 70 or older
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.
Time Frame: 12 months after the last chemotherapy received by the patient
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Louis Tassy, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2020

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-SN@P PROJECT-IPC 2017-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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