HCC Patient Preferences in Japan

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Japan
  • Many Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular cancer (HCC)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCC patients / Cohort 1; 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)]; Oral anti-cancer therapy (Sorafenib, an multiple kinase inhibitor), repeated transarterial chemoembolization (TACE) procedures, and hepatic arterial infusion chemotherapy (HAIC)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Actual): October 7, 2016
• Study Completion (Actual): October 7, 2016

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: HCC; Patient preferences
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 18234