NCT04931329

Brief Summary

The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 10, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

May 10, 2021

Last Update Submit

November 2, 2021

Conditions

Medical OncologyHematologyMolecular Targeted Therapies

Outcome Measures

Primary Outcomes (1)

  • measure patient satisfaction at 3 months

    Patient satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

    3 months

Secondary Outcomes (4)

  • Measurement of caregiver satisfaction

    3 months

  • Measurement of compliance reported by the GIRERD questionnaire

    3 months

  • Measuring the satisfaction of treating physicians and health professionals

    3 months

  • Evaluate the use of the QR code by health professionals/carers

    3 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with onco-heamatologic disease treated with oral treatment (chemotherapy and/or targeted thérapies)

You may qualify if:

  • All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies)

You may not qualify if:

  • All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

RECRUITING

Related Publications (1)

  • Boucheteil M, Leobon S, Baffert KA, Huet S, Darbas T, Le Brun-Ly V, Pestre J, Peyramaure C, Thuillier F, Venat L, Jost J, Touati M, Deluche E. [THERANOVA-LIM: Improving access to information on oral treatments for patients and pharmacists]. Bull Cancer. 2025 Dec 17:S0007-4551(25)00521-1. doi: 10.1016/j.bulcan.2025.10.005. Online ahead of print. French.

    PMID: 41412846DERIVED

Central Study Contacts

Elise Deluche, M.D

CONTACT

+33555056309elise.deluche@chu-limoges.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

June 18, 2021

Study Start

November 2, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

November 10, 2021

Record last verified: 2021-07

Locations

FR(1)