Digestive CancerPRO LinkNCT04008056
Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
A study testing Patient Reported Outcome questionnaire in people with Digestive Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancer
- What is being tested?
- Patient Reported Outcome questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2019to 11 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
- Patient has a Smartphone or access to the internet (via tablet or computer)
- The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant, parturient or breastfeeding
- Patient has already participated in the study
- Patient undergoing first chemotherapy regime
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.
- Conditions
- Digestive Cancer
- Being tested
- Patient Reported Outcome questionnaire
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome questionnaireOther
34 question form to assess patient symptoms
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing chemotherapy | Experimental | Not described Receives: Other: Patient Reported Outcome questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Authorization for preparation of chemotherapy based on clinical information (decision 2)
Yes/no
Measured: Day 1
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)
Yes/no
Measured: Day 1
Secondary outcomes (3)
Cost of unused pouches of prepared chemotherapy according to decisions
Euros
Measured: Day 1
Authorization for preparation of chemotherapy based on biological results (decision 1)
Yes/no
Measured: Day 0
Patient satisfaction with the patient reported outcome questionnaire
System Usability Scale (SUS); score between 0-100 where the higher the score, the more satisfied the patient is.
Measured: Before starting chemotherapy (Up to 72 hours prior to treatment starting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start16 Nov 2019
- Primary completion11 Nov 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Favier, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008056
- Sponsor's protocol ID
- NIMAO/2017-03/MF-01
- Acronym
- PRO Link
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
- ClinicalTrials.gov ID
- NCT04008056
- Acronym / sponsor ID
- PRO Link / NIMAO/2017-03/MF-01
- Conditions
- Digestive Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Nov 2019 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 5 Jul 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 investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing chemotherapy | Experimental | Other: Patient Reported Outcome questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
- Patient has a Smartphone or access to the internet (via tablet or computer)
- The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial
Key exclusion criteria (7 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant, parturient or breastfeeding
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 |
|---|---|---|
| Patient Reported Outcome questionnaire34 question form to assess patient symptoms | Other | Patients undergoing chemotherapy |
Primary outcome
Authorization for preparation of chemotherapy based on clinical information (decision 2)
Time frame: Day 1
Yes/no
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)
Time frame: Day 1
Yes/no
3 secondary outcomes
Cost of unused pouches of prepared chemotherapy according to decisions
Time frame: Day 1
Authorization for preparation of chemotherapy based on biological results (decision 1)
Time frame: Day 0
Patient satisfaction with the patient reported outcome questionnaire
Time frame: Before starting chemotherapy (Up to 72 hours prior to treatment starting)
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 18 Dec 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.
Mireille Favier principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Reported Outcome questionnaire in people with Digestive Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 7 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 18 Dec 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?
Authorization for preparation of chemotherapy based on clinical information (decision 2) (time frame: Day 1). The study lists 2 primary outcomes in all. 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 18 Dec 2025.