Clinical trial NCT03191487: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information
Official title: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
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: 6 months
Secondary outcomes:
measure: The number of prescriptions prepared in advance and administered in full
timeFrame: 6 months
measure: The number of prescriptions prepared in advance and not administered in full
timeFrame: 6 months
measure: The number of prescriptions not prepared in advance
timeFrame: 6 months
measure: Dose-intensity per patient over 6 months of follow-up
timeFrame: 6 months
measure: The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic
timeFrame: 6 months
measure: The number of chemotherapy session postponements that were not anticipated, and the patient was required to come in to the clinic
timeFrame: 6 months
measure: The number of pharmaceutical interventions* accepted by the doctor / the number of prescriptions prepared for the totality of sessions
timeFrame: 6 months
measure: The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up
timeFrame: 6 months
measure: The average number of days between chemotherapy sessions
timeFrame: 6 months
measure: The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment
timeFrame: 6 months
measure: the total period of time spent by the patient in the outpatient clinic
timeFrame: 6 months
measure: The number of prescriptions that were prepared and administered
timeFrame: 6 months
measure: The number of pouches that were prepared, not-administered, but recycled
timeFrame: 6 months
measure: The number of pouches prepared, not administered and destroyed
timeFrame: 6 months
measure: The average number of laboratory assessments required per chemotherapy session
timeFrame: 6 months
measure: Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)
timeFrame: 6 months
measure: Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions
timeFrame: 6 months
measure: Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires
timeFrame: 6 months
measure: Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)
timeFrame: 6 months
measure: Overall costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Montpellier Cedex 5
country: France
facility: Institut de Cancérologie Montpellier
city: Nîmes
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Hôpital de Hautepierre
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
city: Toulouse
country: France
facility: IUCT-Oncopole
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Mireille Favier, PharmD
role: STUDY_DIRECTOR
References: