PAtient-PHYsician Relationship Assessment

Hepatocellular Carcinoma Clinical Trial

— PAPHYRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729230
• Other study ID #: P2020/448
• Status: Completed
• Start date: April 5, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2023
• Est. primary completion date: January 26, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Behavioral:
• Questionnaire
Physician/data nurse and the patients will complete a questionnaire. The physician or data nurse must complete a descriptive form including the patient's age and gender as well as some information about the tumour and the underlying liver disease. Based on the 4 open questions, patient will be classified into 2 groups after assessment of his answers by a group of digestive oncologists and psychologists. Group A includes patients with an accurate perception of the disease whereas group B will gather patients with unrealistic expectations. Psychosocial aspect, quality of the physician's communication, comprehension of the disease and treatment expectations are assessed by multiple-choice questions (Liker scale evaluation). Depression and anxiety were evaluated by the Hospital Anxiety and Depression Scale (HADS) that has been validated as a good scale with a high sensitivity and specificity for depression and anxiety for cancer patients.

Locations

Country	Name	City	State
Belgium	University Hospital Brussels	Brussels

Sponsors (6)

Lead Sponsor	Collaborator
Erasme University Hospital	ASZ Aalst, AZ Sint-Jan AV, CHC Montlegia, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Grand Hôpital de Charleroi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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