Investigating The Experiences of Patients In Immunotherapy Clinical Trials

NCT ID: NCT05435365

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Immunotherapy Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

References

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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.

Reference Type BACKGROUND
PMID: 31415071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12916177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33413830 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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8328197

Identifier Type: -

Identifier Source: org_study_id

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