Trial Condition(s):
Hepatocellular Cancer
HCC patient preferences in Japan
Bayer Identifier:
18234
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Patient preferences for treatments for hepatocellular cancer (HCC) in Japan
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAICBest-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 catheterTimeframe: up to 8 weeks
Secondary Outcome
- Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAICTimeframe: 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 lotTimeframe: up to 8 weeks
- Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAICRated on a 0-100 scalesTimeframe: 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 timeMean 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)Timeframe: 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 timeMean 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)Timeframe: up to 8 weeks
Additional Information
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