Metastatic CancerCAPRINCT02828462
Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
An observational study of Metastatic Cancer and Hematological Malignancy, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Hematological Malignancy
- What is being tested?
- CAPRI
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2016to Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic cancer or hematological malignancy being treated with oral therapy
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Marie FERRUA, marie.ferrua@gustaveroussy.fr
About this study
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
- Metastatic Cancer, Hematological Malignancy
- Being tested
- CAPRI
- Medical subject headings
- Neoplasm Metastasis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPRIOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients using the device Receives: Other: CAPRI | |
| Control | Patients not using the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative dose intensity
RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"
Measured: Assessed every 30 days from randomization up to 6 months
Secondary outcomes (2)
Compliance
Compliance will be assessed using Morisky questionnaire
Measured: Assessed every 30 days from randomization up to 6 months
Toxicity
Grade 3 or 4 using NCICTCAE version 4.0
Measured: Assessed every 30 days from randomization up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start24 Oct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828462
- Sponsor's protocol ID
- 2016-A00254-47
- Other IDs
- 2016/2371
- Acronym
- CAPRI
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2016
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40153795Mir 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.
PubMed 35469070Gerves-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.
PubMed 28193214
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics
- ClinicalTrials.gov ID
- NCT02828462
- Acronym / sponsor ID
- CAPRI / 2016-A00254-47
- Conditions
- Metastatic Cancer, Hematological Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- 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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: CAPRIPatients using the device |
| Control | – | –Patients not using the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic cancer or hematological malignancy being treated with oral therapy
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CAPRI | Other | Experimental |
Primary outcome
Relative dose intensity
Time frame: Assessed every 30 days from randomization up to 6 months
RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"
2 secondary outcomes
Compliance
Time frame: Assessed every 30 days from randomization up to 6 months
Toxicity
Time frame: Assessed every 30 days from randomization up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Derived from this study: PubMed 40153795Minvielle 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.
- Derived from this study: PubMed 35469070Mir 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.
- Derived from this study: PubMed 28193214Gerves-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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Hematological Malignancy, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 10 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Marie Ferrua (0142116148 ext. +33, marie.ferrua@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative dose intensity (time frame: Assessed every 30 days from randomization up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828462, which also lists 3 linked publications.
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 23 Jul 2018.