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NCT Number: NCT05729230

PAtient-PHYsician Relationship Assessment

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brussels

Brussels, 1070, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Perception of prognosis and treatment side effects

    Time frame: 12 months

    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

Secondary outcomes

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

    Time frame: 12 months

    Use of survey completed by the patient and the doctors to assess the primary endpoint

  2. Assessment of patient-reported symptoms of anxiety and depression

    Time frame: 12 months

    Use of survey completed by the patient and the doctors to assess the primary endpoint

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

    Time frame: 12 months

    Use of survey completed by the patient and the doctors to assess the primary endpoint

  4. Evaluation of patient satisfaction with the information received during the consultation

    Time frame: 12 months

    Use of survey completed by the patient and the doctors to assess the primary endpoint

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • ASZ Aalst
  • AZ Sint-Jan AV
  • CHC Montlegia
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Grand Hôpital de Charleroi

Registry information

Official study 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

Acronym: PAPHYRA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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