Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
NCT ID: NCT02828462
Last Updated: 2018-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2016-10-24
2020-10-31
Brief Summary
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The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Experimental
Patients using the device
CAPRI
Control
Patients not using the device
No interventions assigned to this group
Interventions
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CAPRI
Eligibility Criteria
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Inclusion Criteria
* Life expectancy \> 6 months
* Patients with tumour or hematological malignancy being treated at Gustave Roussy
* Patients with oral therapy (cytotoxic or targeted therapies)
* Patients starting therapy
* Patients living in France
* Patients affiliated to a social security system or equivalent
* OMS score from 0 to 2 at the time of inclusion
* Signed inform consent
* Patients able to follow protocol
Exclusion Criteria
* Patients enrolled in a clinical trial ongoing treatment with an experimental compound except in the case where the sponsor agrees that the CAPRI protocol is not intefering with the trial
* Not French speaking patients
* Patients deprived of liberty
* Patients with no internet access or telephone line
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Countries
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Central Contacts
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Facility Contacts
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References
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Minvielle E, Perez-Torrents J, Salma I, Aegerter P, Ferrua M, Ferte C, Leleu H, Mathivon D, Sicotte C, Di Palma M, Scotte F. The Effect of Nurse Navigators in Digital Remote Monitoring in Cancer Care: Case Study Using Structural Equation Modeling. J Med Internet Res. 2025 Mar 28;27:e66275. doi: 10.2196/66275.
Mir O, Ferrua M, Fourcade A, Mathivon D, Duflot-Boukobza A, Dumont S, Baudin E, Delaloge S, Malka D, Albiges L, Pautier P, Robert C, Planchard D, de Botton S, Scotte F, Lemare F, Abbas M, Guillet M, Puglisi V, Di Palma M, Minvielle E. Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial. Nat Med. 2022 Jun;28(6):1224-1231. doi: 10.1038/s41591-022-01788-1. Epub 2022 Apr 25.
Gerves-Pinquie C, Daumas-Yatim F, Lalloue B, Girault A, Ferrua M, Fourcade A, Lemare F, Dipalma M, Minvielle E. Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial. BMC Health Serv Res. 2017 Feb 13;17(1):133. doi: 10.1186/s12913-017-2066-x.
Other Identifiers
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2016/2371
Identifier Type: OTHER
Identifier Source: secondary_id
2016-A00254-47
Identifier Type: -
Identifier Source: org_study_id
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