HCC Patient Preferences in Japan

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02616692

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

24.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 9, 2016

Actual Primary Completion Date :

Oct 7, 2016

Actual Study Completion Date :

Oct 7, 2016

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC [up to 8 weeks]
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

Secondary Outcome Measures

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) [up to 8 weeks]
Specific scale responses: dislike a lot, dislike, neither like or dislike, like, like a lot
Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC [up to 8 weeks]
Rated 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 time [up to 8 weeks]
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)
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 [up to 8 weeks]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Japan

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT02616692

Other Study ID Numbers:

18234

First Posted:

Nov 30, 2015

Last Update Posted:

Sep 27, 2017

Last Verified:

Sep 1, 2017

Keywords provided by Bayer

HCC

Patient preferences

Additional relevant MeSH terms:

Liver Neoplasms

Carcinoma, Hepatocellular

Sorafenib

Study Results

No Results Posted as of Sep 27, 2017