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

Colorectal Neoplasms Clinical Trial

— ChimioPal  

Official title:

Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03191487
• Other study ID #: PREPS/2016/MF-01
• Status: Withdrawn
• Phase: N/A
• First received: June 15, 2017
• Last updated: June 15, 2017
• Start date: April 2018
• Est. completion date: November 2019

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon Cedex 9
France	Institut de Cancérologie Montpellier	Montpellier Cedex 5
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes
France	CHRU de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	IUCT-Oncopole	Toulouse
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of prescriptions prepared in advance and administered in full		6 months
Secondary	The number of prescriptions prepared in advance and not administered in full		6 months
Secondary	The number of prescriptions not prepared in advance		6 months
Secondary	Dose-intensity per patient over 6 months of follow-up		6 months
Secondary	The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic		6 months
Secondary	The number of chemotherapy session postponements that were not anticipated, and the patient was required to come in to the clinic		6 months
Secondary	The number of pharmaceutical interventions* accepted by the doctor / the number of prescriptions prepared for the totality of sessions	*a pharmaceutical intervention = request for prescription verification following results/information	6 months
Secondary	The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up		6 months
Secondary	The average number of days between chemotherapy sessions	The average number of days of inter-session lag: ?(days between 2 sessions-expected days between 2 sessions)/(c-1)	6 months
Secondary	The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment		6 months
Secondary	the total period of time spent by the patient in the outpatient clinic		6 months
Secondary	The number of prescriptions that were prepared and administered		6 months
Secondary	The number of pouches that were prepared, not-administered, but recycled		6 months
Secondary	The number of pouches prepared, not administered and destroyed		6 months
Secondary	The average number of laboratory assessments required per chemotherapy session		6 months
Secondary	Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)		6 months
Secondary	Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions		6 months
Secondary	Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires		6 months
Secondary	Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)		6 months
Secondary	Overall costs	The cost of pouches, consultations, examinations and transport will be estimated in both arms. Staff time, optimized due to the new organization, will be quantified. The point of view of health insurance and the establishment will be considered. Any gains will be weighed against the cost of the experimental strategy.	6 months