Cancer Clinical Trial
Official title:
An Observational Study Investigating The Experiences of Patients In Immunotherapy Clinical Trials
| NCT number | NCT05435365 |
| Other study ID # | 8328197 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2024 |
| Est. completion date | August 2026 |
It has been observed before that participation in medical trials has been in favor of specific demographic groups. But research pointing out which trial attributes impact participation positively or negatively is sparse. This study invites various participants to collect more data on their immunotherapy clinical experiences. The goal is to know which factors always limit how patients participate or complete the medical study they are first interested in. The data obtained in the trial will be assessed through a variety of demographic lenses to discover patterns that might improve the experience of immunotherapy patients in the future.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient has self-identified as planning to participate in an interventional clinical trial using immunotherapy - Patient has been diagnosed with a type of cancer - Patient is a minimum of 18 years or older Exclusion Criteria: - Patient has an ECOG score of 4 or higher - Patient is not able to provide consistent digital reporting as per study requirements - Patient does not complete Informed Consent Form |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Hussain-Gambles M. Ethnic minority under-representation in clinical trials. Whose responsibility is it anyway? J Health Organ Manag. 2003;17(2):138-43. doi: 10.1108/14777260310476177. — View Citation
Loree JM, Anand S, Dasari A, Unger JM, Gothwal A, Ellis LM, Varadhachary G, Kopetz S, Overman MJ, Raghav K. Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol. 2019 Oct 1;5(10):e191870. doi: 10.1001/jamaoncol.2019.1870. Epub 2019 Oct 10. — View Citation
Ma MA, Gutierrez DE, Frausto JM, Al-Delaimy WK. Minority Representation in Clinical Trials in the United States: Trends Over the Past 25 Years. Mayo Clin Proc. 2021 Jan;96(1):264-266. doi: 10.1016/j.mayocp.2020.10.027. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to enroll in an immunotherapy clinical trial | 3 months | ||
| Primary | Rate of patients who remain in immunotherapy clinical trial to trial completion | 12 months |
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