- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275675
Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy (ORCA)
June 3, 2022 updated by: University Hospital, Clermont-Ferrand
Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy: Observational and Transversal Study
The pharmacist, as a specialist of medications, occupies a strategic position: he participates in a global care of their patients.
Dispensation is the pharmaceutical act which associates with the dispensing of medications "the pharmaceutical analysis of the medical prescription if it exists, the possible preparation of the doses to be administered and the provisions of the information and advices necessary for the proper use of medications".
The pharmacist ensures that the quality and safety of the dispensation is guaranteed at all times by limiting as far as possible the risks associated with an error in delivery, prescription, drug interactions or undetected contraindications, inadequate dosages or non-compliance with treatment.
The longer the patient feels satisfied with the stage of delivery of his treatment, the better his adherence to treatment is, and the less he will encounter poor compliance.
Oncology has particularly benefited in recent years from the introduction of numerous drugs with the aim of extending the duration of response in a growing number of indications.
Traditionally in oncology, chemotherapy treatments are administered intravenously by trained personnel and rarely managed by the patient at home.
Recently, there has been a growing choice of oral formulations, whether for conventional hormonal, anticancer therapies or targeted therapies.
These specialties are now widely available in community pharmacies.
Oral administration puts the patient at the center of his therapeutic management.
He must take his medication alone.
Adherence and compliance are therefore particularly important here for an optimal risk-benefit ratio.
This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and whose treatment is provided by their community pharmacies.
It also needs to provide information about the reasons for their poor adherence to treatment (personal factors, factors attributable to treatment, factors attributable to the care system).
Patients will be recruited and interviewed by contacting several departments of the Clermont-Ferrand University Hospital (CHU de Clermont-Ferrand), who are used to caring for patients with cancerous diseases (hematology, urology, respiratory, gastro-enterology).
The data collected in this study may be used for subsequent studies evaluating new management strategies or therapeutic education to improve adherence to patient treatment.
Study Overview
Detailed Description
This observational and transversal study will be conducted as a survey by contacting each eligible patients after complete information by the oncologist.
After acceptance, the patients will received a postal mail with the questionnaire and a stamped envelope for the return of completed questionnaire.
All the completed questionnaires will be recorded in a specific REDCap database for analysis.
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63003
- CHU de Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and whose treatment is provided by their community pharmacies.
It also needs to provide information about the reasons for their poor adherence to treatment (personal factors, factors attributable to treatment, factors attributable to the care system).
Description
Inclusion Criteria:
- Patient (or helping people) receiving oral cancer chemotherapy or oral hormone therapy delivered in community pharmacy for the treatment of cancer
- Non-opposition to participation in the study
Exclusion Criteria:
- Patient unable to understand or respond to questionnaires
- Age < 18
- Legal incapacity (person deprived of liberty or under guardianship)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with cancer chemotherapy
This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer and whose treatment is provided by their community pharmacies.
|
All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy
Time Frame: at day 1
|
(visual analogic scale 0-100)
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists
Time Frame: at day 1
|
(visual analogic scale 0-100)
|
at day 1
|
Assessment of patients' satisfaction based on type of cancer
Time Frame: at day 1
|
at day 1
|
|
Assessment of patients' satisfaction based on type of treatment received
Time Frame: at day 1
|
at day 1
|
|
Assessment of patients' satisfaction based on number of medications taken per day
Time Frame: at day 1
|
at day 1
|
|
Assessment of patients' satisfaction based on patient characteristics
Time Frame: at day 1
|
age, gender, professional status, marital status, level of study
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David BALAYSSAC, PhD, PharmD, CHU de Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2017
Primary Completion (Actual)
April 11, 2019
Study Completion (Actual)
April 11, 2019
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2022
Last Update Submitted That Met QC Criteria
June 3, 2022
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CHU-344
- 2017-A01139-44 (Other Identifier: 2017-A01139-44)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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