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

Hepatocellular Carcinoma Clinical Trial

— PERCEPTION1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823754
• Other study ID #: APHP210481
• Status: Completed
• Start date: July 12, 2021
• Est. completion date: November 4, 2022

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patient over 18 years of age

2. Patient informed and not objecting to participate in the study

3. Patient with advanced hepatocellular carcinoma.

4. Patient treated with systemic therapy

Exclusion Criteria:

1. Locoregional treatment combined with systemic treatment

2. Pregnancy in progress

3. Candidate for surgery or locoregional therapy

4. Patient with state medical aid (AME)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.
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.

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Loh KP, Mohile SG, Lund JL, Epstein R, Lei L, Culakova E, McHugh C, Wells M, Gilmore N, Mohamed MR, Kamen C, Aarne V, Conlin A, Bearden J 3rd, Onitilo A, Wittink M, Dale W, Hurria A, Duberstein P. Beliefs About Advanced Cancer Curability in Older Patients, Their Caregivers, and Oncologists. Oncologist. 2019 Jun;24(6):e292-e302. doi: 10.1634/theoncologist.2018-0890. Epub 2019 Apr 23. — View Citation

Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12months
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	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
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 (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

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