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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03959774
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959774


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

Locations
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France
Institut Sainte Catherine Not yet recruiting
Avignon, France
Contact: Sylvie Kircher         
Principal Investigator: Sylvie Kircher, Dr         
CHI des Alpes du Sud Not yet recruiting
Gap, France
Contact: Olivier Guillem         
Principal Investigator: Olivier Guillem         
Institut Paoli-Calmettes Not yet recruiting
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 Not yet recruiting
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

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03959774     History of Changes
Other Study ID Numbers: E-SN@P PROJECT-IPC 2017-029
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Paoli-Calmettes:
Elderly population
digital monitoring

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases