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

Last updated: February 23, 2026
Sponsor: Fred Hutchinson Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Neoplasms

Carcinoma

Cancer/tumors

Treatment

Best Practice

Patient Navigation

Clinical Study ID

NCT06484595
RG1124291
NCI-2024-04530
P30CA015704
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years of age

  • Identified as potentially eligible for an open clinical trial by clinical trialpre-screening

  • Have ≥ 1 health related social need, defined by

  • Food insecurity, housing instability, transportation challenges, or financialinstability documented in the Supportive Cancer Care Questionnaire in EpicElectronic Medical Record (EPIC), OR

  • Concerns about insurance, cost of trial, additional trial visits, travel,transportation, childcare/eldercare, OR unable to take time off work, etc., asdocumented 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 socialneeds screening question asked by our Research Coordinator: "During your cancertreatment, are you interested in assistance with transportation, food, housing,financial resources, or other barriers to treatment?"

  • Able to speak English

Exclusion

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 asclinicaltrials.gov identifier (CT ID): NCT04960787

  • Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Best Practice
Phase:
Study Start date:
September 23, 2024
Estimated Completion Date:
January 26, 2026

Study Description

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.

Connect with a study center

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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