Investigating The Experiences of Patients In Immunotherapy Clinical Trials
December 29, 2023 updated by: Power Life Sciences Inc.
An Observational Study Investigating The Experiences of Patients In Immunotherapy Clinical Trials
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael B Gill
- Phone Number: (415) 900-4227
- Email: bask@withpower.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with cancer who are actively considering enrolling in an immunotherapy interventional clinical trials, but have not yet completed enrollment and randomization in said clinical trial.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients who decide to enroll in an immunotherapy clinical trial
Time Frame: 3 months
|
3 months
|
|
Rate of patients who remain in immunotherapy clinical trial to trial completion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 22, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 8328197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.