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NCT Number: NCT04823754

Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma "PERCEPTION1"

atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Avicenne, Bobigny, France

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About this study

atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient over 18 years of age
  • Patient informed and not objecting to participate in the study
  • Patient with advanced hepatocellular carcinoma.
  • Patient treated with systemic therapy

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

Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.

Other

Administation of two surveys to included patients, about the perception of the disease and the expectations related to the treatment.

The physician will be asked to complete a survey on his or her perception of the prognosis and information received by the patient.

Primary outcomes

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

    Time frame: 12months

    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. 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

  3. 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

  4. Evaluate the association between individual prognosis expectation (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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma

Acronym: PERCEPTION1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Jul 11, 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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