Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04931329
Other study ID # 87RI21_0010
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2021
Est. completion date June 2022

Study information

Verified date July 2021
Source University Hospital, Limoges
Contact Elise Deluche, M.D
Phone +33555056309
Email elise.deluche@chu-limoges.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Recent developments in oral chemotherapy and targeted therapies have radically changed cancer patient management; ambulatory care is now common. Oral therapies afford many advantages, improving patient quality of life and autonomy by reducing hospital stays and involving patients in their own care. Optimising the care of cancer patients at home requires the coordinated intervention of hospital and town healthcare professionals and involvement of the patient to detect, prevent, and manage adverse events, avoid drug interactions, and educate patients. Preliminary work in haematology has highlighted (n = 31 patients) the interest of a "drug vigilance card" in three indications (Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia and Multiple Myeloma) with an increase in the town-hospital link. This is an prospective cohort study. Following the announcement consultation, in addition to the personalised care plan, the information about the treatment will be contained in a drug monitoring card that will be given to the patient by the health professional (doctor or nurse). This drug monitoring card should be presented to the health professionals by the patient. During the entire period of treatment, the patient will have a card.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies) Exclusion Criteria: - All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU de Limoges Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Measurement of caregiver satisfaction Caregiver satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110) 3 months
Secondary Measurement of compliance reported by the GIRERD questionnaire patients will have to answer shorts questions on GIRERD* questionnaire to evaluate their Medication compliance to oral anticancer drugs.
*X. Girerd, O. Hanon, K. Anagnostopoulos, C. Ciupek, J.J. Mourad, S. Consoli Assessment of antihypertensive compliance using a self-administered questionnaire: development and use in a hypertension clinic Presse Med, 30 (2001), pp. 1044-1048
3 months
Secondary Measuring the satisfaction of treating physicians and health professionals Treating physicians ad health professionnals satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110) 3 months
Secondary Evaluate the use of the QR code by health professionals/carers The use of the QR code with be evaluated by counting how many times it will be flashed during study period. 3 months
See also
  Status Clinical Trial Phase
Completed NCT02824042 - Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole Phase 1
Completed NCT02253420 - COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients Phase 1
Completed NCT02357953 - Transpulmonary Thermodilution Using an Implented Central Venous Access Port N/A
Completed NCT02645357 - Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients N/A
Terminated NCT02138812 - Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel Phase 1
Recruiting NCT05356182 - A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies N/A
Terminated NCT02368951 - Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2) Phase 1
Not yet recruiting NCT05423808 - Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients. N/A
Terminated NCT02439346 - Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel Phase 1
Recruiting NCT05385718 - Ezra Faster Scan Study
Completed NCT02457351 - Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study Phase 1
Completed NCT02906423 - Results From a Health System-wide Implementation of a Quality of Life Questionnaire N/A
Completed NCT01409135 - A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4 Phase 1
Not yet recruiting NCT02327806 - The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance N/A
Completed NCT02639091 - Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors Phase 1
Completed NCT02366949 - Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel Phase 1
Not yet recruiting NCT06097533 - Improvement of Quality of Life by Cannabinoids in Oncologic Patients Phase 2/Phase 3
Completed NCT02427490 - A Problem-Solving Intervention for Family Caregivers in Palliative Oncology N/A
Recruiting NCT05359848 - A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy N/A