Clinical trial NCT05729230: PAtient-PHYsician Relationship Assessment
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: systemic treatment
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: ASZ Aalst
name: Grand Hôpital de Charleroi
name: AZ Sint-Jan AV
name: CHC Montlegia
First posted: 2023-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced hepatocellular carcinoma eligible for systemic treatment

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Perception of prognosis and treatment side effects
timeFrame: 12 months
Secondary outcomes:
measure: Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
timeFrame: 12 months
measure: Assessment of patient-reported symptoms of anxiety and depression
timeFrame: 12 months
measure: Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.
timeFrame: 12 months
measure: Evaluation of patient satisfaction with the information received during the consultation
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Gontran Verset, MD
role: PRINCIPAL_INVESTIGATOR
References: