NCT03275675

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2019

Completed
Last Updated

June 6, 2022

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

July 31, 2017

Last Update Submit

June 3, 2022

Conditions

Keywords

CancerOral chemotherapyCommunity PharmacySatisfaction

Outcome Measures

Primary Outcomes (1)

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

    (visual analogic scale 0-100)

    at day 1

Secondary Outcomes (5)

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

    at day 1

  • Assessment of patients' satisfaction based on type of cancer

    at day 1

  • Assessment of patients' satisfaction based on type of treatment received

    at day 1

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

    at day 1

  • Assessment of patients' satisfaction based on patient characteristics

    at day 1

Study Arms (1)

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

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

Patients with cancer chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

NeoplasmsPersonal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David BALAYSSAC, PhD, PharmD

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2017

First Posted

September 7, 2017

Study Start

June 20, 2017

Primary Completion

April 11, 2019

Study Completion

April 11, 2019

Last Updated

June 6, 2022

Record last verified: 2018-10

Locations