CancerORCANCT03275675
Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy
An observational study of Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oral anticancer medications
- Type of treatment
- Pill or oral medicine
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2017to 11 Apr 2019
- Phase
- Observational
- 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
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).
Who may be able to join
- 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
Who cannot join
- Patient unable to understand or respond to questionnaires
- Age < 18
- Legal incapacity (person deprived of liberty or under guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Oral anticancer medications
- Keywords
- Cancer, Oral chemotherapy, Community Pharmacy, Satisfaction
- Medical subject headings
- Neoplasms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral anticancer medicationsDrug
All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oral anticancer medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy
(visual analogic scale 0-100)
Measured: at day 1
Secondary outcomes (5)
Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists
(visual analogic scale 0-100)
Measured: at day 1
Assessment of patients' satisfaction based on type of cancer
Measured: at day 1
Assessment of patients' satisfaction based on type of treatment received
Measured: at day 1
Assessment of patients' satisfaction based on number of medications taken per day
Measured: at day 1
Assessment of patients' satisfaction based on patient characteristics
age, gender, professional status, marital status, level of study
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start20 Jun 2017
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David BALAYSSAC, PhD, PharmD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275675
- Sponsor's protocol ID
- CHU-344
- Other IDs
- 2017-A01139-44
- Acronym
- ORCA
- Status last verified
- Oct 2018
- First submitted
- 31 Jul 2017
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy: Observational and Transversal Study
- ClinicalTrials.gov ID
- NCT03275675
- Acronym / sponsor ID
- ORCA / CHU-344
- Conditions
- Cancer
- Keywords
- Cancer, Oral chemotherapy, Community Pharmacy, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer chemotherapy | – | Drug: Oral anticancer medicationsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient unable to understand or respond to questionnaires
- Age < 18
- Legal incapacity (person deprived of liberty or under guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral anticancer medicationsAll the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies) | Drug | Patients with cancer chemotherapy |
Primary outcome
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)
5 secondary outcomes
Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists
Time frame: at day 1
Assessment of patients' satisfaction based on type of cancer
Time frame: at day 1
Assessment of patients' satisfaction based on type of treatment received
Time frame: at day 1
Assessment of patients' satisfaction based on number of medications taken per day
Time frame: at day 1
Assessment of patients' satisfaction based on patient characteristics
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David BALAYSSAC, PhD, PharmD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Clermont-Ferrand at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2022.