Clinical trial · Observational
Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental
- description
- Patients using the device
- interventionNames
- Other: CAPRI
- label
- Control
- description
- Patients not using the device
Primary outcomes (1)
- measure
- Relative dose intensity
- timeFrame
- Assessed every 30 days from randomization up to 6 months
- description
- RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"
Secondary outcomes (2)
- measure
- Compliance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients (male or female) aged \> 18 years * 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 being treated with hormonotherapy only * 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
References
Publications (3)
- DERIVEDMinvielle 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. PMID 40153795
- DERIVEDMir 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. PMID 35469070
- DERIVEDGerves-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. PMID 28193214