HCC Patient Preferences in Japan

NCT02616692 | Completed

• 1 other identifier: 18234
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer

Keywords

HCC; Patient preferences

Outcome Measures

Primary Outcomes (1)

• Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC

  Best-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

  up to 8 weeks

Secondary Outcomes (5)

• 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

• Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC

  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

  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

  up to 8 weeks

Study Arms (1)

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)]

Interventions

Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)] DRUG

Oral anti-cancer therapy (Sorafenib, an multiple kinase inhibitor), repeated transarterial chemoembolization (TACE) procedures, and hepatic arterial infusion chemotherapy (HAIC)

HCC patients / Cohort 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular cancer (HCC)

You may qualify if:

• 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

You may not qualify if:

• None are currently considered

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Liver Neoplasms; Patient Preference

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: November 30, 2015
• Study Start: May 9, 2016
• Primary Completion: October 7, 2016
• Study Completion: October 7, 2016
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

JP (1)