Clinical trial NCT04607889: A Study to Learn More About What Japanese Patients With Solid Tumors Think About Taking Medicine That is Based on Their Genetic Information
Official title: Measurement of Patient Views on the Attributes of Cancer Genomic Medicine in Japan (Patient View Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Genomic Profiling
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 605
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: Best-Worst Scaling scores showing patient preferences for the attributes of the process of taking panel tests
timeFrame: Up to 25 minutes
Secondary outcomes:
measure: Best-Worst Scaling scores showing doctor preferences for the attributes of the process of taking panel tests
timeFrame: Up to 25 minutes
measure: Ranking of Best-Worst scaling scores for patients and for doctors
timeFrame: Up to 25 minutes
measure: Patient and doctor willingness to try/offer panel tests based on different hypothetical conditions of panel tests and drugs in cancer genomic medicine
timeFrame: Up to 25 minutes
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many locations
Study officials:
References: