PAtient-PHYsician Relationship Assessment (PAPHYRA)

Evaluation of the Patient-physician Relationship During the Initial Consultation Prior to the Introduction of a New Systemic Treatment for Advanced Hepatocellular Carcinoma: Information Needs, Prognostic Awareness, Treatment Expectations Regarding Efficacy and Side Effects

I) Introduction Patients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process. Nevertheless, this kind of discussion is frequently lacking, and consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy.

II) Type of study:

Prospective, observational, non-interventional multicentric study

III) Outcomes III.1) Primary Outcome Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.

III.2) Secondary Outcomes

• Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
• Evaluation of patient satisfaction with the information received during the consultation
• Assessment of patient-reported symptoms of anxiety and depression
• Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.

IV) Recruitment All consecutive patients with a new systemic treatment prescribed for HCC in participating centres will be included for a period of 1 year.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Behavioral: Questionnaire

Detailed Description

Patients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process. Nevertheless, this kind of discussion is frequently lacking, and consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • University Hospital Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced hepatocellular carcinoma eligible for systemic treatment

Description

Inclusion Criteria:

• diagnose of advanced hepatocellular carcinoma by histology or radiology using the EASL criteria
• ≥ 18 years old
• willing to participate in the study, being capable of consenting and sign the informed consent
• not candidate for curative treatment or locoregional therapy
• any line systemic therapy that has been validated by the local hepatic tumor board.

Exclusion Criteria:

• Locoregional treatment combined with systemic treatment
• Pregnancy in progress
• Candidate for surgery or locoregional therapy
• Patient with state medical aid (AME)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of prognosis and treatment side effects	Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician. Use of survey completed by the patient and the doctors to assess the primary endpoint	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.	Use of survey completed by the patient and the doctors to assess the primary endpoint	12 months
Evaluation of patient satisfaction with the information received during the consultation	Use of survey completed by the patient and the doctors to assess the primary endpoint	12 months
Assessment of patient-reported symptoms of anxiety and depression	Use of survey completed by the patient and the doctors to assess the primary endpoint	12 months
Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.	Use of survey completed by the patient and the doctors to assess the primary endpoint	12 months

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: AZ Sint-Jan AV; Cliniques universitaires Saint-Luc- Université Catholique de Louvain; Grand Hôpital de Charleroi; ASZ Aalst; CHC MontLégia

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: systemic treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: P2020/448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No