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HCC Patient Preferences in Japan

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02616692
Enrollment
120
Registered
2015-11-30
Start date
2016-05-09
Completion date
2016-10-07
Last updated
2017-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Cancer

Keywords

HCC, Patient preferences

Brief summary

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.

Interventions

DRUGHepatocellular 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)

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAICup to 8 weeksBest-Worst Scaling scores for each attribute: 1. Prevents formation of new blood vessels 2. 2 tablets twice a day 3. Risk of hand-foot skin reaction 4. Risk of diarrhea 5. Risk of stopping treatment because of side effects 6. Artery branches in liver are plugged 7. Several hour medical procedure under sedation with hospitalization 8. Medical procedure repeated when needed 9. Risk of liver damage 10. Ongoing chemotherapy drugs to the liver 11. Container and a catheter implanted in the body 12. Risk of fever, abdominal pain, and nausea 13. Risk of complications with catheter

Secondary

MeasureTime frameDescription
Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAICup to 8 weeks
Like/dislike ratings of each treatment attribute (Extent of patients like or dislike of different treatment attributes)up to 8 weeksSpecific scale responses: dislike a lot, dislike, neither like or dislike, like, like a lot
Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAICup to 8 weeksRated on a 0-100 scales
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 timeup to 8 weeksMean 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)
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 timeup to 8 weeksMean 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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026