A Study to Learn More About What Japanese Patients With Solid Tumors Think About Taking Medicine That is Based on Their Genetic Information

Measurement of Patient Views on the Attributes of Cancer Genomic Medicine in Japan (Patient View Study)

Researchers are looking for a better way to treat people with solid tumors. One new way is called cancer genomic medicine. In cancer genomic medicine, doctors use tests to look at the genetic information in a solid tumor. These tests are called panel tests. The results of the panel tests help doctors to choose the best type of medicine to treat that tumor.

In this study, the researchers want to learn more about what a large number of patients with solid tumors think are the burden and benefits of taking panel tests. The researchers also want to know what doctors who treat patients with solid tumors think about panel tests.

The study will include about 650 men and women in Japan who are at least 20 years old. About 340 of the participants will be patients with solid tumors who are taking medicine to help treat their tumors. About 310 of the patients will be doctors who are treating patients with solid tumors.

There will be 3 parts in this study. Part 1 will include patients with solid tumors. Parts 2 and 3 will include patients with solid tumors and doctors who are treating patients with solid tumors. In each part, the patients and doctors will answer questions about what they think of panel tests. During Part 1, all of the patients will answer questions in a teleconference. Some of the patients and physicians in Part 2 will also answer questions in a teleconference. During Part 2 and Part 3, all of the patients and doctors will complete an online questionnaire.

Study Overview

• Status: Completed
• Conditions: Cancer Genomic Profiling
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Actual): 605

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Part 1:

Adult female and male patients with a diagnosis of a solid tumor, who have taken or tried to take a panel test will be enrolled in the study.

Part 2 and Part 3 (patients):

Female and male patients with a diagnosis of a solid tumor and will be enrolled in the study.

Part 2 and Part 3 (physicians):

Physicians with experience in genomic medicine will be preferred as study participants but the sample will not be limited to them.

Description

Inclusion Criteria:

Part 1:

• Adult female or male patient
• Diagnosis of a solid tumor

• Patients familiar with panel tests to be defined as:

  • Patients who have taken a panel test

  • Patients who have not taken a panel test

    • Patients who have tried or considered taking a panel test
    • Patients who have been offered a panel test but refused
• Signed informed consent
• Is 20 years of age or older

Part 2 and Part 3 (patients):

• Female or male patient
• Diagnosis of a solid tumor (lung, or one of rare tumors defined by National Cancer Center and MHLW: mouth and lip, ovary and fallopian tube, urinary tract, soft tissue sarcoma, neuroendocrine, glioma, oropharynx, salivary, testis, parathesis, teratoma, skin melanoma, small intestine, nasal, nasal sinus, skin appendages, mesothelioma, GIST, vaginal and vulvar, thymic, nasopharynx, bone sarcoma, anus, uterine carcinosarcoma, penile, extragonadal germ cell, embryonal carcinoma, mucosa melanoma, pineal, brain and CNS, eye, peripheral nerve, trachea, melanoma of uvea, meningioma, histocytic and dendritic cell, trophoblastic tumor of placenta, Kaposi sarcoma, middle ear)
• Sees the doctor for cancer treatment on regular basis (at least once every three months)
• Signed informed consent
• Is 20 years of age or older

Part 2 and Part 3 (physician):

• Has prescribed anti-cancer drugs to patients with a solid tumor (lung or one of rare tumors defined by National Cancer Center and MHLW: mouth and lip, ovary and fallopian tube, urinary tract, soft tissue sarcoma, neuroendocrine, glioma, oropharynx, salivary, testis, parathesis, teratoma, skin melanoma, small intestine, nasal, nasal sinus, skin appendages, mesothelioma, GIST, vaginal and vulvar, thymic, nasopharynx, bone sarcoma, anus, uterine carcinosarcoma, penile, extragonadal germ cell, embryonal carcinoma, mucosa melanoma, pineal, brain and CNS, eye, peripheral nerve, trachea, melanoma of uvea, meningioma, histocytic and dendritic cell, trophoblastic tumor of placenta, Kaposi sarcoma, middle ear) in the last 3 months.
• Signed informed consent

Exclusion Criteria:

Part 1:

• Non-Japanese speakers
• Declaring to be too unwell to perform an interview

Part2 and Part 3 (patients):

• Non-Japanese speakers
• Declaring to be too unwell to complete the survey
• Participation in the pilot study

Part 2 and Part 3 (physician):

- Non-Japanese speakers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Part 1 - Attribute development; An elicitation phase to develop the list of attributes and levels based on literature review and telephone interviews with patients.	Other: Survey; Interviews with study participants will be conducted by telephone or teleconference. The interview will focus on the participants experience with genomic tests, with the expectations, reasons for taking or declining it, hurdles encountered, satisfaction among the key themes to be discussed.; Other Names: Interviews
Part 2 - Pilot study; A pilot phase consisting of a self-administered, online survey, to be completed by patients and physicians, followed by telephone interviews with a subsample of participants.	Other: Survey; Interviews with study participants will be conducted by telephone or teleconference. The interview will focus on the participants experience with genomic tests, with the expectations, reasons for taking or declining it, hurdles encountered, satisfaction among the key themes to be discussed.; Other Names: Interviews
Part 3 - Main study; The main study, with a self-administered, online survey, to be completed by cancer patients and physicians.	Other: Survey; Interviews with study participants will be conducted by telephone or teleconference. The interview will focus on the participants experience with genomic tests, with the expectations, reasons for taking or declining it, hurdles encountered, satisfaction among the key themes to be discussed.; Other Names: Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-Worst Scaling scores showing patient preferences for the attributes of the process of taking panel tests	Respondents will choose "Best" or "Worst" for prepared questions.	Up to 25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-Worst Scaling scores showing doctor preferences for the attributes of the process of taking panel tests	Doctors will choose "Best" or "Worst" for prepared questions.	Up to 25 minutes
Ranking of Best-Worst scaling scores for patients and for doctors	Attributes will be ranked based on the responses by patients and doctors.	Up to 25 minutes
Patient and doctor willingness to try/offer panel tests based on different hypothetical conditions of panel tests and drugs in cancer genomic medicine	Willingness to try questions based on hypothetical conditions would enable the policy makers and thought leaders improve the clinical practice of cancer genomic medicine in a patient-centric way.	Up to 25 minutes

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No