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

NCT ID: NCT06484595

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2026-03-31

Brief 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.

Detailed 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ARM I (Clinical trial navigator, SOC)

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 via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services.

Group Type: EXPERIMENTAL

Best Practice

Intervention Type: OTHER

Receive SOC supportive care services

Patient Navigation

Intervention Type: BEHAVIORAL

Receive clinical trial navigator guide services

Arm II (SOC)

Patients receive SOC supportive care services.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive SOC supportive care services

Interventions

Best Practice

Receive SOC supportive care services

Intervention Type: OTHER

Patient Navigation

Receive clinical trial navigator guide services

Intervention Type: BEHAVIORAL

Other Intervention Names

standard of care; standard therapy; Patient Navigator Program

Eligibility Criteria

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, etc., 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andy Hill Cancer Research Endowment (CARE) Fund

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Mendoza, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2024-04530

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1124291

Identifier Type: -

Identifier Source: org_study_id