Investigating The Experiences of Patients In Immunotherapy Clinical Trials

NCT05435365 | Not Yet Recruiting

• 1 other identifier: 8328197
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immunotherapy; Cancer

Keywords

Immunotherapy; Cancer; Diversity In Immunotherapy Clinical Trials

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in an immunotherapy clinical trial

  3 months

• Rate of patients who remain in immunotherapy clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael B Gill

  Power Life Sciences

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12