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NCT Number: NCT02616692

HCC Patient Preferences in Japan

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.

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Key information

Conditions

Hepatocellular Cancer Behavior Digestive System Diseases Digestive System Neoplasms Health Behavior Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

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

    Time frame: up to 8 weeks

    Best-Worst Scaling scores for each attribute:

    • Prevents formation of new blood vessels
    • 2 tablets twice a day
    • Risk of hand-foot skin reaction
    • Risk of diarrhea
    • Risk of stopping treatment because of side effects
    • Artery branches in liver are plugged
    • Several hour medical procedure under sedation with hospitalization
    • Medical procedure repeated when needed
    • Risk of liver damage
    • Ongoing chemotherapy drugs to the liver
    • Container and a catheter implanted in the body
    • Risk of fever, abdominal pain, and nausea
    • Risk of complications with catheter

Secondary outcomes

  1. 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

  2. Like/dislike ratings of each treatment attribute (Extent of patients like or dislike of different treatment attributes)

    Time frame: up to 8 weeks

    Specific scale responses: dislike a lot, dislike, neither like or dislike, like, like a lot

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

    Time frame: up to 8 weeks

    Rated on a 0-100 scales

  4. 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

    Time frame: 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)

  5. 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Patient Preferences for Treatments for Hepatocellular Cancer (HCC) in Japan

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2015
Registry last updated
Sep 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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