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

NCT04823754 | Completed

• 1 other identifier: APHP210481
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, systemic treatment

Outcome Measures

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.

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

  12months

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

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

  12 months

• Assessment of patient-reported symptoms of anxiety and depression

  12 months

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

  12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.

You may qualify if:

• 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

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

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Avicenne

Bobigny, 93009, France

Location

Assistance Publique - Hôpitaux de Paris

Paris, France

Location

Related Publications (3)

• 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.

  PMID: 31015317 BACKGROUND

• 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.

  PMID: 29158371 BACKGROUND

• Nault JC, Sritharan N, Verset G, Borbath I, Lequoy M, Allaire M, Regnault H, Colle I, Orlent H, Sinapi I, Moreno C, Larrey E, Sidali S, Hollande C, Amaddeo G, Pol S, Nahon P, Ganne-Carrie N, Levy V, Bloch-Queyrat C; Paris Liver Cancer Group; Trepo E, Bouattour M. Patient and physician expectations regarding disease and treatment of advanced HCC: The prospective PERCEPTION1 study. JHEP Rep. 2024 Aug 22;6(11):101192. doi: 10.1016/j.jhepr.2024.101192. eCollection 2024 Nov.

  PMID: 39741695 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

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

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: July 12, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: July 11, 2023

Record last verified: 2023-06

Locations

FR (2)