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

Primary Purpose

Colorectal Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ChimioPal
Usual pathways
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Sainte Catherine
  • Institut de Cancérologie Montpellier
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • CHRU de Strasbourg - Hôpital de Hautepierre
  • CHRU de Toulouse - Hôpital de Rangueil
  • IUCT-Oncopole

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ChimioPal

Standard

Arm Description

Systematic collection of clinical and laboratory toxicities.

The usual management and logistic pathways will be respected.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The number of prescriptions prepared in advance and administered in full
The number of prescriptions prepared in advance and not administered in full
The number of prescriptions not prepared in advance
Dose-intensity per patient over 6 months of follow-up
The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic
The number of chemotherapy session postponements that were not anticipated, and the patient was required to come in to the clinic
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
The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up
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)
The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment
the total period of time spent by the patient in the outpatient clinic
The number of prescriptions that were prepared and administered
The number of pouches that were prepared, not-administered, but recycled
The number of pouches prepared, not administered and destroyed
The average number of laboratory assessments required per chemotherapy session
Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)
Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions
Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires
Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)
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.

Full Information

First Posted
June 15, 2017
Last Updated
June 15, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03191487
Brief Title
Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information
Acronym
ChimioPal
Official Title
Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no Financial agreement
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ChimioPal
Arm Type
Experimental
Arm Description
Systematic collection of clinical and laboratory toxicities.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
The usual management and logistic pathways will be respected.
Intervention Type
Other
Intervention Name(s)
ChimioPal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual pathways
Intervention Description
In the standard arm, the usual management and logistic pathways will be respected. Only extra data collection is required by this study.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The number of prescriptions prepared in advance and administered in full
Time Frame
6 months
Title
The number of prescriptions prepared in advance and not administered in full
Time Frame
6 months
Title
The number of prescriptions not prepared in advance
Time Frame
6 months
Title
Dose-intensity per patient over 6 months of follow-up
Time Frame
6 months
Title
The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic
Time Frame
6 months
Title
The number of chemotherapy session postponements that were not anticipated, and the patient was required to come in to the clinic
Time Frame
6 months
Title
The number of pharmaceutical interventions* accepted by the doctor / the number of prescriptions prepared for the totality of sessions
Description
*a pharmaceutical intervention = request for prescription verification following results/information
Time Frame
6 months
Title
The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up
Time Frame
6 months
Title
The average number of days between chemotherapy sessions
Description
The average number of days of inter-session lag: ∑(days between 2 sessions-expected days between 2 sessions)/(c-1)
Time Frame
6 months
Title
The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment
Time Frame
6 months
Title
the total period of time spent by the patient in the outpatient clinic
Time Frame
6 months
Title
The number of prescriptions that were prepared and administered
Time Frame
6 months
Title
The number of pouches that were prepared, not-administered, but recycled
Time Frame
6 months
Title
The number of pouches prepared, not administered and destroyed
Time Frame
6 months
Title
The average number of laboratory assessments required per chemotherapy session
Time Frame
6 months
Title
Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)
Time Frame
6 months
Title
Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions
Time Frame
6 months
Title
Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires
Time Frame
6 months
Title
Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)
Time Frame
6 months
Title
Overall costs
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Favier, PharmD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Facility Name
Institut de Cancérologie Montpellier
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
CHRU de Strasbourg - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHRU de Toulouse - Hôpital de Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
IUCT-Oncopole
City
Toulouse
ZIP/Postal Code
31100
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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