Informations générales (source: ClinicalTrials.gov)
Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
Observational
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
octobre 2016
octobre 2020
12 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Marie FERRUA | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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