HCC Patient Preferences in Japan
- Conditions
- Hepatocellular Cancer
- Interventions
- Drug: Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)]
- Registration Number
- NCT02616692
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
None are currently considered
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HCC patients / Cohort 1 Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)] Patient preferences associated with oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC and their perceptions regarding the respective treatment characteristics
- Primary Outcome Measures
Name Time Method 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:
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 Outcome Measures
Name Time Method 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)