An interventional study of ChimioPal and Usual pathways in Colorectal Neoplasms, sponsored by Centre Hospitalier Universitaire de Nīmes. Withdrawn at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-19.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Supportive care
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.
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
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
Browse Colorectal Neoplasms studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 89 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Systematic collection of clinical and laboratory toxicities.
Other: ChimioPal
The usual management and logistic pathways will be respected.
Other: Usual pathways
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.
In the standard arm, the usual management and logistic pathways will be respected. Only extra data collection is required by this study.
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
Time frame: 6 months
The number of prescriptions prepared in advance and administered in full
Time frame: 6 months
The number of prescriptions prepared in advance and not administered in full
Time frame: 6 months
The number of prescriptions not prepared in advance
Time frame: 6 months
Dose-intensity per patient over 6 months of follow-up
Time frame: 6 months
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
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
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
Time frame: 6 months
The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up
Time frame: 6 months
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)
Time frame: 6 months
The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment
Time frame: 6 months
the total period of time spent by the patient in the outpatient clinic
Time frame: 6 months
The number of prescriptions that were prepared and administered
Time frame: 6 months
The number of pouches that were prepared, not-administered, but recycled
Time frame: 6 months
The number of pouches prepared, not administered and destroyed
Time frame: 6 months
The average number of laboratory assessments required per chemotherapy session
Time frame: 6 months
Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)
Time frame: 6 months
Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions
Time frame: 6 months
Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires
Time frame: 6 months
Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)
Time frame: 6 months
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.
Time frame: 6 months
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Nīmes →