Solid Tumor, AdultCPV2-0NCT03977766
Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit
A study testing Chemotherapy prevalidation in people with Solid Tumor, Adult, run by Institut Paoli-Calmettes.
Trial summary
The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Chemotherapy prevalidation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 15 Apr 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age <80 (if age>70 years, a G8 score>14 is required)
- ECOG<3
- Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
- Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
- Familiar with digital tools
Who cannot join
- Emergency
- patient feeling unease with the use of a smartphone
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit
The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.
After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)
- Conditions
- Solid Tumor, Adult
- Being tested
- Chemotherapy prevalidation
- Keywords
- digital application, outpatients chemotherapy, chemotherapy validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy prevalidationProcedure or surgery
Outpatient Chemotherapy prevalidation will done
- with the help of a nurse, using the digital application, for cycle 2 and 3.
- by the patient alone, using the digital application, for cycle 4 and 5.
| Study group | Role | What they receive |
|---|---|---|
| nurse then patient digital prevalidation of chemotherapy | Experimental | Outpatient Chemotherapy prevalidation will done
* with the help of a nurse, using the digital application, for cycle 2 and 3.
* by the patient alone, using the digital application, for cycle 4 and 5. Receives: Procedure: Chemotherapy prevalidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the digital application
Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loui Tassy, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977766
- Sponsor's protocol ID
- CPV 2.0-IPC 2018-054
- Acronym
- CPV2-0
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit
- ClinicalTrials.gov ID
- NCT03977766
- Acronym / sponsor ID
- CPV2-0 / CPV 2.0-IPC 2018-054
- Conditions
- Solid Tumor, Adult
- Keywords
- digital application, outpatients chemotherapy, chemotherapy validation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 6 Jun 2019 (actual)
- 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 aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.
After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nurse then patient digital prevalidation of chemotherapy | Experimental | Procedure: Chemotherapy prevalidationOutpatient Chemotherapy prevalidation will done * with the help of a nurse, using the digital application, for cycle 2 and 3. * by the patient alone, using the digital application, for cycle 4 and 5. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age <80 (if age>70 years, a G8 score>14 is required)
- ECOG<3
- Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
- Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
- Familiar with digital tools
Key exclusion criteria (2 listed)
- Emergency
- patient feeling unease with the use of a smartphone
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 |
|---|---|---|
| Chemotherapy prevalidationOutpatient Chemotherapy prevalidation will done * with the help of a nurse, using the digital application, for cycle 2 and 3. * by the patient alone, using the digital application, for cycle 4 and 5. | Procedure or surgery | nurse then patient digital prevalidation of chemotherapy |
Primary outcome
Sensitivity of the digital application
Time frame: 6 weeks
Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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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.
Loui Tassy principal investigator
Institut Paoli-Calmettes
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy prevalidation in people with Solid Tumor, Adult, run by Institut Paoli-Calmettes.
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 5 inclusion and 2 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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Dominique Genre, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the digital application (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2019.