Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials (GUIDE)

Fred Hutchinson Cancer Center (FHCC)

Status: Enrolling

Conditions: Digestive System Carcinoma; Genitourinary System Carcinoma; Breast Carcinoma

Treatments: Other: Best Practice; Behavioral: Patient Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06484595

RG1124291

P30CA015704 (U.S. NIH Grant/Contract)

NCI-2024-04530 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age

• Identified as potentially eligible for an open clinical trial by clinical trial pre-screening (operating in breast, gastrointestinal [GI], and genitourinary [GU] clinics)

• 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, OR unable to take time off work documented by clinical trial pre-screening (CTPS), OR
  • Medicaid insurance documented in EPIC

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

ARM I (Clinical trial navigator, SOC)

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation

Other: Best Practice

Arm II (SOC)

Active Comparator group

Description:

Patients receive SOC supportive care services.

Treatment:

Other: Best Practice