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Colorectal NeoplasmsChimioPalNCT03191487

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

A study testing ChimioPal and Usual pathways in people with Colorectal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
ChimioPal and Usual pathways
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesFrance
Study dates
Apr 2018to Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • Institut de Cancérologie Montpellier

    Montpellier, 34298

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CHRU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

  • CHRU de Toulouse - Hôpital de Rangueil

    Toulouse, 31059

  • IUCT-Oncopole

    Toulouse, 31100

Other trials in France

About this study

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

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.

Read the detailed description

Compare the two arms of the study in terms of:

  1. each element contributing to the primary criterium;
  2. the quality of chemotherapy related care;
  3. logistics;
  4. patient satisfaction with respect to support for chemotherapy care;
  5. 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)
  6. Comparison of the overall cost of care in both arms and estimated cost of the strategy
Being tested
ChimioPal, Usual pathways
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChimioPalOther

    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 pathwaysOther

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

Study groups in NCT03191487
Study groupRoleWhat they receive
ChimioPalExperimentalSystematic collection of clinical and laboratory toxicities.
Receives: Other: ChimioPal
StandardActive comparatorThe usual management and logistic pathways will be respected.
Receives: Other: Usual pathways

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (20)

  1. The number of prescriptions prepared in advance and administered in full

    Measured: 6 months

  2. The number of prescriptions prepared in advance and not administered in full

    Measured: 6 months

  3. The number of prescriptions not prepared in advance

    Measured: 6 months

  4. Dose-intensity per patient over 6 months of follow-up

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up

    Measured: 6 months

  9. 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)

    Measured: 6 months

  10. The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment

    Measured: 6 months

  11. the total period of time spent by the patient in the outpatient clinic

    Measured: 6 months

  12. The number of prescriptions that were prepared and administered

    Measured: 6 months

  13. The number of pouches that were prepared, not-administered, but recycled

    Measured: 6 months

  14. The number of pouches prepared, not administered and destroyed

    Measured: 6 months

  15. The average number of laboratory assessments required per chemotherapy session

    Measured: 6 months

  16. Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)

    Measured: 6 months

  17. Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions

    Measured: 6 months

  18. Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires

    Measured: 6 months

  19. Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)

    Measured: 6 months

  20. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study startApr 2018 (estimated)
  3. Primary completionNov 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Why it stopped: no Financial agreement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191487
Sponsor's protocol ID
PREPS/2016/MF-01
Acronym
ChimioPal
Status last verified
Jun 2017
First submitted
15 Jun 2017
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ChimioPal and Usual pathways in people with Colorectal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.

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