Clinical trial · Interventional
Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information
Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no Financial agreement
Summary
Brief summary (as posted)
The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ChimioPal | Other | — | UNRESOLVED |
| Usual pathways | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ChimioPal
- description
- Systematic collection of clinical and laboratory toxicities.
- interventionNames
- Other: ChimioPal
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- The usual management and logistic pathways will be respected.
- interventionNames
- Other: Usual pathways
Primary outcomes (1)
- measure
- The rate of prescriptions for chemotherapy in the outpatient clinic prepared at the latest the day before a session (except for predefined, limited stability products) and administered in full, per patient, during a follow-up period of 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient was informed about the implementation of the study, its objectives, constraints and patient rights * The patient has given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 6 months of follow-up * The patient is treated via anti-cancer chemotherapy for colorectal cancer * The patient is starting a new adjuvant or metastatic chemotherapy protocol with a follow-up in a day-clinic setting * The patient has already used a smartphone, or desires to learn how, or is accompanied by a person who can help the patient use a smartphone * The anticipated chemotherapy treatment corresponds to one of the following protocols: cetuximab, FOLFIRI, FOLFIRI-aflibercept, FOLFIRI-bevacizumab, FOLFIRI-cetuximab, FOLFIRI-panitumumab, Folfirinox, Folfirinox-bevacizumab, Folfoxiri, Folfoxiri-bevacizumab, FOLFOX 4 simplified, FOLFOX 4 simplified - bevacizumab, FOLFOX 4 simplified - cetuximab, FOLFOX 4 simplified - panitumumab, Irinotecan-cetuximab, LV5FU2 simplified, panitumumab, XELOX. Exclusion Criteria: * The patient is participating in another study, or has participated in another study within the past 3 months, that may influence the results or conclusions of the present trial * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, or is an adult under guardianship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The planned chemotherapy regimen includes weekly treatment cycles * Patient who is incapable of using a smartphone either by himself/herself or via another helping person
References
Publications (0)
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