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

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IPC NET
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Elderly population, digital monitoring

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Sainte Catherine
  • CHI des Alpes du Sud
  • Institut Paoli-Calmettes
  • CHU Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

breast or colorectal or lung cancer, age 70 or older

Arm Description

breast or colorectal or lung cancer, age 70 or older

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
July 27, 2020
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT03959774
Brief Title
Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Acronym
E-SN@P PROJECT
Official Title
Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2020 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer
Keywords
Elderly population, digital monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
breast or colorectal or lung cancer, age 70 or older
Arm Type
Experimental
Arm Description
breast or colorectal or lung cancer, age 70 or older
Intervention Type
Device
Intervention Name(s)
IPC NET
Intervention Description
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
Primary Outcome Measure Information:
Title
demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.
Description
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.
Time Frame
12 months after the last chemotherapy received by the patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 70 years, 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33491223778
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Tassy, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Kircher
First Name & Middle Initial & Last Name & Degree
Sylvie Kircher, Dr
Facility Name
CHI des Alpes du Sud
City
Gap
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Guillem
First Name & Middle Initial & Last Name & Degree
Olivier Guillem
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENRE Dominique, MD
Phone
33(0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Louis Tassy, MD
Facility Name
CHU Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Bouhalassass, MD
First Name & Middle Initial & Last Name & Degree
Rabia Bouhalassass

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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