Breast CancerE-SN@P PROJECTNCT03959774
Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
A study testing IPC NET in people with Breast Cancer and Colorectal Cancer, run by Institut Paoli-Calmettes at 4 sites in France.
Trial summary
adherence of digital follow-up in a population of elderly patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- IPC NET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Dec 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut Sainte Catherine
Avignon
Sylvie Kircher
Sylvie Kircher, Dr
CHI des Alpes du Sud
Gap
Olivier Guillem
Olivier Guillem
Institut Paoli-Calmettes
Marseille, 13009
GENRE Dominique, MD, 33(0) 4 91 22 37 78, drci.up@ipc.unicancer.fr
Louis Tassy, MD
CHU Nice
Nice
Rabia Bouhalassass, MD
Rabia Bouhalassass
About this study
adherence of digital follow-up in a population of elderly patients.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer
- Being tested
- IPC NET
- Keywords
- Elderly population, digital monitoring
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPC NETDevice
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 group | Role | What they receive |
|---|---|---|
| breast or colorectal or lung cancer, age 70 or older | Experimental | breast or colorectal or lung cancer, age 70 or older Receives: Device: IPC NET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the last chemotherapy received by the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start30 Dec 2020 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Tassy, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959774
- Sponsor's protocol ID
- E-SN@P PROJECT-IPC 2017-029
- Acronym
- E-SN@P PROJECT
- Status last verified
- Jul 2020
- First submitted
- 21 May 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT03959774
- Acronym / sponsor ID
- E-SN@P PROJECT / E-SN@P PROJECT-IPC 2017-029
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer
- Keywords
- Elderly population, digital monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast or colorectal or lung cancer, age 70 or older | Experimental | Device: IPC NETbreast or colorectal or lung cancer, age 70 or older |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 70 years,
- Patient with an indication of adjuvant chemotherapy showing:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPC NETa 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 | Device | breast or colorectal or lung cancer, age 70 or older |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Tassy, MD principal investigator
Institut Paoli-Calmettes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPC NET in people with Breast Cancer and Colorectal Cancer, run by Institut Paoli-Calmettes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.