HCC Patient Preferences in Japan

Hepatocellular Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616692
• Other study ID #: 18234
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: September 26, 2017
• Start date: May 9, 2016
• Est. completion date: October 7, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Neoplasms

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC	Rated on a 0-100 scales	up to 8 weeks
Secondary	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
Secondary	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

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.