Solid Malignant TumorANTICIPRONCT05552066
Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
A study testing Standard follow up and short circuit in people with Solid Malignant Tumor, run by Center Eugene Marquis at 1 site in France.
Trial summary
The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO. The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignant Tumor
- What is being tested?
- Standard follow up and short circuit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Patient treated for solid malignancy
- Patient starting a new chemotherapy or immunotherapy protocol.
- Patient receiving one of the following intravenous antineoplastic treatments in day hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)
- Affiliated and beneficiary to a social security system
- Informed and written consent
- Note1: may be used in combination with tyrosine kinase inhibitors (TKIs) Note 2 :may be used in combination with bevacizumab, cetuximab or panitumumab
Who cannot join
- Patient treated in neo-adjuvant situation for breast cancer
- Does not have a connected device (smartphone, tablet or computer)
- Does not have an internet connection
- Difficulty in filling out a questionnaire
- Protected adult or deprived of her liberty
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.
The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.
Read more
The study is planed in 2 steps.
- st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
- nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
- Conditions
- Solid Malignant Tumor
- Being tested
- Standard follow up, short circuit
- Keywords
- PRO (Patient reported outcomes), Chemotherapy, immunotherapy, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard follow upOther
Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire
short circuitOther
Patients included in the post phase will have to complete the "cem@santé" application. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation).
| Study group | Role | What they receive |
|---|---|---|
| front phase | Other | The current circuit remains unchanged (medical or nursing validation to confirm chemotherapy administration). Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. Receives: Other: Standard follow up |
| Post Phase | Other | A short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation). Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. Receives: Other: short circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of stay in day hospital unit
Assess the impact on the duration of stay of an anticipated personalization of the stay in HDJ based on a platform of analysis of the PROs collected the day before and the implementation of a short circuit
Measured: Immediately after the chemotherapy
Secondary outcomes (3)
patient satisfaction
Assessed by EORTC OUT-PATSAT7 ( patient satisfaction with cancer care core questionnaire).
satisfaction score between 0 (no satisfaction) and 100 (high satisfaction)
Measured: Immediately after the chemotherapy
Caregiver satisfaction
Assessed by self questionnaire
Measured: Month3;Month6
Health related patient quality of life
Assessed by EQ5D-5L (EuroQuol Five Dimension - Five Level Health Survey questionnaire) The scale has five subcomponents with scores from 1 (best) to 5 (worst)
Measured: Immediately after the chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start11 Jan 2022
- Primary completion13 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Malignant TumorStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552066
- Sponsor's protocol ID
- 2022-3-29-001
- Acronym
- ANTICIPRO
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2022
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
- ClinicalTrials.gov ID
- NCT05552066
- Acronym / sponsor ID
- ANTICIPRO / 2022-3-29-001
- Conditions
- Solid Malignant Tumor
- Keywords
- PRO (Patient reported outcomes), Chemotherapy, immunotherapy, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 23 Sep 2022 (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 present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.
The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.
The study is planed in 2 steps.
- st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
- nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).
| Arm | Type | Receives |
|---|---|---|
| front phase | Other | Other: Standard follow upThe current circuit remains unchanged (medical or nursing validation to confirm chemotherapy administration). Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. |
| Post Phase | Other | Other: short circuitA short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation). Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than 18 years
- Patient treated for solid malignancy
- Patient starting a new chemotherapy or immunotherapy protocol.
- Patient receiving one of the following intravenous antineoplastic treatments in day hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)
- Affiliated and beneficiary to a social security system
Key exclusion criteria (6 listed)
- Patient treated in neo-adjuvant situation for breast cancer
- Does not have a connected device (smartphone, tablet or computer)
- Does not have an internet connection
- Difficulty in filling out a questionnaire
- Protected adult or deprived of her liberty
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 |
|---|---|---|
| Standard follow upPatients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire | Other | front phase |
| short circuitPatients included in the post phase will have to complete the "cem@santé" application. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation). | Other | Post Phase |
Primary outcome
Duration of stay in day hospital unit
Time frame: Immediately after the chemotherapy
Assess the impact on the duration of stay of an anticipated personalization of the stay in HDJ based on a platform of analysis of the PROs collected the day before and the implementation of a short circuit
3 secondary outcomes
patient satisfaction
Time frame: Immediately after the chemotherapy
Caregiver satisfaction
Time frame: Month3;Month6
Health related patient quality of life
Time frame: Immediately after the chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard follow up and short circuit in people with Solid Malignant Tumor, run by Center Eugene Marquis 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of stay in day hospital unit (time frame: Immediately after the chemotherapy). 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 1 Aug 2025.