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出境医 / 临床实验 / Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment (E-SN@P PROJECT)

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

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

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Lung Cancer Device: IPC NET Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Estimated Study Start Date : December 30, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: breast or colorectal or lung cancer, age 70 or older
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
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr

Locations
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France
Institut Sainte Catherine
Avignon, France
Contact: Sylvie Kircher         
Principal Investigator: Sylvie Kircher, Dr         
CHI des Alpes du Sud
Gap, France
Contact: Olivier Guillem         
Principal Investigator: Olivier Guillem         
Institut Paoli-Calmettes
Marseille, France, 13009
Contact: GENRE Dominique, MD    33(0) 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: Louis Tassy, MD         
CHU Nice
Nice, France
Contact: Rabia Bouhalassass, MD         
Principal Investigator: Rabia Bouhalassass         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Louis Tassy, MD Institut Paoli-Calmettes
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 28, 2020
Estimated Study Start Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Official Title  ICMJE Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: breast or colorectal or lung cancer, age 70 or older
breast or colorectal or lung cancer, age 70 or older
Intervention: Device: IPC NET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		119
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959774
Other Study ID Numbers  ICMJE E-SN@P PROJECT-IPC 2017-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louis Tassy, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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