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

NCT03191487 | Withdrawn

• 1 other identifier: PREPS/2016/MF-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

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

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  This criterion is aggregated per patient but its components are collected for each prescription, according to the following coding: * Prescription prepared in advance and administered in full: 1 * Prescription prepared in advance but not administered in full: 0 * Prescription not prepared in advance : 0 For each patient, the sum of the results for each prescription will be the numerator. The denominator is the number of prescriptions during 6 months follow-up for each patient. The limited stability products that will necessarily be prepared at the last minute are: * Aflibercept * Panitumumab * Raltitrexed

  6 months

Secondary Outcomes (20)

• The number of prescriptions prepared in advance and administered in full

  6 months

• The number of prescriptions prepared in advance and not administered in full

  6 months

• The number of prescriptions not prepared in advance

  6 months

• Dose-intensity per patient over 6 months of follow-up

  6 months

• The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic

  6 months

Study Arms (2)

ChimioPal

EXPERIMENTAL

Systematic collection of clinical and laboratory toxicities.

Other: ChimioPal

Standard

ACTIVE COMPARATOR

The usual management and logistic pathways will be respected.

Other: Usual pathways

Interventions

ChimioPal OTHER

Systematic collection of clinical and laboratory toxicities (TXs) during the 2-4 days preceding a chemotherapy (CT) session (48H before a session (D-2 towards the end of the afternoon) and a maximum of 96h before sessions occurring on Mondays (D-4 towards the end of the afternoon). Clinical TX data will be collected via ChimioPal (a self-questionnaire administered by smartphone) and laboratory TX data will be collected via Apicrpyt (secure messaging service) or a fax-to-email service. Data flow management by a nurse dedicated to this activity in each centre will be implemented. If the results of the assessment do not authorize CT, additional assessments may be prescribed. If the experimental data transmission does not occur, the usual pathways will be implemented. Patient training on how to use a smart phone and the questionnaire will be performed by a nurse before the start of the first chemotherapy session, with reminders at the following sessions if required.

ChimioPal

Usual pathways OTHER

In the standard arm, the usual management and logistic pathways will be respected. Only extra data collection is required by this study.

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Institut Sainte Catherine

Avignon, 84918, France

Location

Institut de Cancérologie Montpellier

Montpellier, 34298, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

IUCT-Oncopole

Toulouse, 31100, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mireille Favier, PharmD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: April 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

FR (6)