Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information (ChimioPal)

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Colorectal Neoplasms

Treatments: Other: ChimioPal; Other: Usual pathways

Study type: Interventional

Funder types: Other

Identifiers

NCT03191487

PREPS/2016/MF-01

Details and patient eligibility

About

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.

Full description

Compare the two arms of the study in terms of:

A. each element contributing to the primary criterium;

B. the quality of chemotherapy related care;

C. logistics;

D. patient satisfaction with respect to support for chemotherapy care;

E. the feasibility and acceptability of the organization by patients will be assessed by the rate of optimal use of toxicity collection tools and patient satisfaction rates relative to the tool (experimental arm)

F. Comparison of the overall cost of care in both arms and estimated cost of the strategy

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

ChimioPal

Experimental group

Description:

Systematic collection of clinical and laboratory toxicities.

Treatment:

Other: ChimioPal

Standard

Active Comparator group

Description:

The usual management and logistic pathways will be respected.

Treatment:

Other: Usual pathways