HCC Patient Preferences in Japan

• ClinicalTrials.gov Identifier: NCT02616692
• Recruitment Status: Completed
• First Posted: November 30, 2015
• Last Update Posted: September 27, 2017
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Hepatocellular Cancer	Drug: Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)]

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Patient Preferences for Treatments for Hepatocellular Cancer (HCC) in Japan
• Actual Study Start Date: May 9, 2016
• Actual Primary Completion Date: October 7, 2016
• Actual Study Completion Date: October 7, 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
HCC patients / Cohort 1; 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)

Outcome Measures

Primary Outcome Measures :

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:

   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 :

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)

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular cancer (HCC)

Criteria

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

Contacts and Locations

Locations

Japan

Many Locations, Japan

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02616692
• Other Study ID Numbers: 18234
• First Posted: November 30, 2015
• Last Update Posted: September 27, 2017
• Last Verified: September 2017

Keywords provided by Bayer:

HCC; Patient preferences

Additional relevant MeSH terms:

Liver Neoplasms; Carcinoma, Hepatocellular; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Sorafenib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action