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CompletedNCT03275675ORCAUpdated Jun 6, 2022

Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy

An observational study in Cancer, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cancer

Keywords

  • Cancer
  • Oral chemotherapy
  • Community Pharmacy
  • Satisfaction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

Exclusion Criteria:

  • Patient unable to understand or respond to questionnaires
  • Age \< 18
  • Legal incapacity (person deprived of liberty or under guardianship)
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
104 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Oral anticancer medications

Interventions

  • DrugOral anticancer medications

    All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)

05

What researchers measure

Primary outcomes

  1. Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy

    (visual analogic scale 0-100)

    Time frame: at day 1

Secondary outcomes

  1. Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists

    (visual analogic scale 0-100)

    Time frame: at day 1

  2. Assessment of patients' satisfaction based on type of cancer

    Time frame: at day 1

  3. Assessment of patients' satisfaction based on type of treatment received

    Time frame: at day 1

  4. Assessment of patients' satisfaction based on number of medications taken per day

    Time frame: at day 1

  5. Assessment of patients' satisfaction based on patient characteristics

    age, gender, professional status, marital status, level of study

    Time frame: at day 1

06

Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, Auvergne 63003, France
07

Registry details

Key details

Study ID
NCT03275675
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Jun 20, 2017
Primary completion
Apr 11, 2019
Completion
Apr 11, 2019
Last update
Jun 6, 2022

Study contacts

David BALAYSSAC, PhD, PharmD
principal investigator · CHU de Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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