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| ID | Type | Description | Link |
|---|---|---|---|
| 2016/2371 | Other Identifier | CSET Number |
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The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Patients using the device |
| |
| Control | Patients not using the device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPRI | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative dose intensity | RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen" | Assessed every 30 days from randomization up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Compliance will be assessed using Morisky questionnaire | Assessed every 30 days from randomization up to 6 months |
| Toxicity | Grade 3 or 4 using NCICTCAE version 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic cancer or hematological malignancy being treated with oral therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Ferrua | Contact | 0142116148 | +33 | marie.ferrua@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Recruiting | Villejuif | Val De Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40153795 | Derived | 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. | |
| 35469070 | Derived |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Assessed every 30 days from randomization up to 6 months |
| 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. |
| 28193214 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |