HCC Patient Preferences in Japan

Study Overview
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Brief Summary
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This non-interventional cross-sectional online survey will evaluate preferences among patients with self-reported HCC. The survey will ask patients to express their preferences regarding descriptions of HCC treatments, which will include sorafenib (which will be described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that patients may have received before completing this online survey were given regardless of their participation in this survey. Questions also include asking patients to rank various treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative to each other. The ultimate goal is to better understand patient perceptions of these treatments and to provide evidence to help in patients' and physicians' treatment decision-making in HCC.

Official Title
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Patient Preferences for Treatments for Hepatocellular Cancer (HCC) in Japan

Conditions
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Hepatocellular Cancer

Intervention / Treatment
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* Drug: Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following eligibility criteria will be used: Have a diagnosis of HCC Are > 20 years of age Reside in Japan Are able to read and understand Japanese to provide informed consent and complete the survey instrument Exclusion Criteria: None are currently considered

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC patients / Cohort 1<br>Patient preferences associated with oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC and their perceptions regarding the respective treatment characteristics | Drug: Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)]<br>* Oral anti-cancer therapy (Sorafenib, an multiple kinase inhibitor), repeated transarterial chemoembolization (TACE) procedures, and hepatic arterial infusion chemotherapy (HAIC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC | Best-Worst Scaling scores for each attribute: Prevents formation of new blood vessels 2 tablets twice a day Risk of hand-foot skin reaction Risk of diarrhea Risk of stopping treatment because of side effects Artery branches in liver are plugged Several hour medical procedure under sedation with hospitalization Medical procedure repeated when needed Risk of liver damage Ongoing chemotherapy drugs to the liver Container and a catheter implanted in the body Risk of fever, abdominal pain, and nausea Risk of complications with catheter | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC |  | up to 8 weeks | 
| Like/dislike ratings of each treatment attribute (Extent of patients like or dislike of different treatment attributes) | Specific scale responses: dislike a lot, dislike, neither like or dislike, like, like a lot | up to 8 weeks | 
| Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC | Rated on a 0-100 scales | up to 8 weeks | 
| Maximum acceptable risk of hand-foot skin reaction willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time | Mean percentage acceptable risk on a scale from 0% (will not accept any risk of hand-foot skin reaction) to 100% (will definitely accept a risk of hand-foot skin reaction) | up to 8 weeks | 
| Maximum acceptable risk of life-threatening side effect willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time | Mean percentage acceptable risk on a scale from 0% (will not accept any risk of life-threatening side effect) to 100% (will definitely accept a risk of life-threatening side effect) | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Patient preferences