An observational study in Hepatocellular Cancer, sponsored by Bayer. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-09-27.
Sponsored by Bayer · Observational
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 120 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Patients with hepatocellular cancer (HCC)
The following eligibility criteria will be used:
Exclusion Criteria:
None are currently considered
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)
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
Time frame: up to 8 weeks
Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC
Time frame: 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 lot
Time frame: up to 8 weeks
Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC
Rated on a 0-100 scales
Time frame: 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
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)
Time frame: 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
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)
Time frame: up to 8 weeks
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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