Investigating The Experiences of Patients In Immunotherapy Clinical Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immunotherapy, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study Investigating The Experiences of Patients In Immunotherapy Clinical Trials
Overview
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.
Primary outcome measures
- Number of patients who decide to enroll in an immunotherapy clinical trial [Time frame: 3 months]
- Rate of patients who remain in immunotherapy clinical trial to trial completion [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 31415071
- 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. PMID 12916177
- 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. PMID 33413830
Identifiers
NCT: NCT05435365 · 8328197