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

NCT ID: NCT04607889

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 605 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-09-15

Brief Summary

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.

Conditions

Cancer Genomic Profiling

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Part 1 - Attribute development

An elicitation phase to develop the list of attributes and levels based on literature review and telephone interviews with patients.

Survey

Intervention Type: OTHER

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.

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.

Survey

Intervention Type: OTHER

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.

Part 3 - Main study

The main study, with a self-administered, online survey, to be completed by cancer patients and physicians.

Survey

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Interviews

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many locations

Multiple Locations, , Japan

Countries

Japan

References

Suehara Y, Hasegawa K, Majima Y, Mita N, Barbier S, Bogoeva N, Kato S. Patient and physician preferences for cancer panel testing in Japan: a best-worst scaling study. BMJ Open. 2025 Aug 26;15(8):e097620. doi: 10.1136/bmjopen-2024-097620.

Reference Type: DERIVED

PMID: 40858382 (View on PubMed)

Related Links

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Other Identifiers

21421

Identifier Type: -

Identifier Source: org_study_id