check_circleStudy Completed

Hepatocellular Cancer

Bayer Identifier:

18234

ClinicalTrials.gov Identifier:

NCT02616692

EudraCT Number:

Not Available

EU CT Number:

Not Available
HCC patient preferences in Japan

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • 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

Trial summary

Enrollment Goal
120
Trial Dates
May 2016 - October 2016
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • 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
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC
    Rated on a 0-100 scales
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.