PAtient-PHYsician Relationship Assessment

NCT05729230 | Completed

• 1 other identifier: P2020/448
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

systemic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.

  12 months

• Assessment of patient-reported symptoms of anxiety and depression

  12 months

• Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.

  12 months

• Evaluation of patient satisfaction with the information received during the consultation

  12 months

Interventions

Questionnaire BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced hepatocellular carcinoma eligible for systemic treatment

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• ASZ Aalst: collaborator
• Grand Hôpital de Charleroi: collaborator
• AZ Sint-Jan AV: collaborator
• CHC Montlegia: collaborator

Study Sites (1)

University Hospital Brussels

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gontran Verset, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: April 5, 2021
• Primary Completion: January 26, 2023
• Study Completion: January 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)