Preferences of Patients Treated With Oral Cancer Drugs an... | NCT05970471

Studies
Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital

NCT05970471

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Dec 12, 2025Actual

Enrollment

167Actual

Phase

Not provided

Conditions

Preference, Patient
Pharmacist-Patient Relations
Caregiver
Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2023Actual

Primary Completion Date

Dec 4, 2025Actual

Completion Date

Dec 4, 2025Actual

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Jul 24, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

167Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preferences of patients	utility associated with each attribute	12 months

Secondary Outcomes

Measure	Description	Time Frame
Preferences of cargivers and healthcare profesionnals	utility associated with each attribute	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

of patients:

Main inclusion Criteria:

Patients with lung, prostate breast, prostate or renal cancer;
Patients with oral cancer drugs;
Patients accepted to take par in pharmaceutical consultation in hospital.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

240 patients - 60 Caregivers - 360 healhcare professionnals (pharmacist, oncologists, general practitioners)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virginie NERICH, PhD	CHU de Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besançon		Besançon		25030	France

Condition Browse Module

MeSH Terms

ID	Term
D057240	Patient Preference
D009369	Neoplasms
D003110	Colonic Neoplasms
D001943	Breast Neoplasms
D008175	Lung Neoplasms
D011471	Prostatic Neoplasms
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D017060	Patient Satisfaction
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided