Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials

Status: closed to accrual

This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Despite this, only a small number of cancer patients participate in clinical trials. There are many different items that contribute to low clinical trial participation, including health-related social needs (HRSN) and financial burden. Guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (GUIDE), is a program that uses a trained clinical trial navigator, or "Guide", to work with identified potential cancer clinical trial patients to help them recognize and remove HRSN and financial barriers preventing clinical trial participation. A clinical trial navigation intervention, like GUIDE, may help increase participation and diversity in cancer clinical trials.

Inclusion Criteria

Patients ≥ 18 years of age
Identified as potentially eligible for an open clinical trial by clinical trial pre-screening
Have ≥ 1 health related social need, defined by * Food insecurity, housing instability, transportation challenges, or financial instability documented in the Supportive Cancer Care Questionnaire in Epic Electronic Medical Record (EPIC), OR * Concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare/eldercare, OR unable to take time off work, ect., as documented by clinical trial pre-screening (CTPS) or provider, OR * Medicaid insurance (including Medicaid pending) documented in EPIC, OR * Respond affirmatively (yes, maybe, possibly, I think so, etc.) to the social needs screening question asked by our Research Coordinator: “During your cancer treatment, are you interested in assistance with transportation, food, housing, financial resources, or other barriers to treatment?”;
Able to speak English

Exclusion Criteria

Unable to speak English
Children, adolescents, and teens under the age of 18 years
Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787
Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization

PRIMARY OBJECTIVES:

I. To determine preliminary efficacy of the GUIDE intervention.

II. To determine acceptability, appropriateness, and feasibility of a clinical trial navigation program.

SECONDARY OBJECTIVE:

I. To quantify GUIDE program costs for patients and health systems.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide for up to 6 months. Patients also receive standard of care (SOC) supportive care services.

ARM II: Patients receive SOC supportive care services.

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Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials

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