NCT03191487

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Neoplasms

Interventions

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

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2017-06-19
• Last updated: 2017-06-19

Locations

6 sites across 1 country: France