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

NCT06484595 | Completed

• 3 other identifiers: RG1124291NCI-2024-04530P30CA015704
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Participant perceptions of the intervention (acceptability, appropriateness, feasibility)

  Acceptability, appropriateness, and feasibility of the intervention will be assessed as potential themes in the qualitative interviews with patients in the GUIDE intervention arm of the trial.

  At 6 months

Secondary Outcomes (4)

• Staff time and effort to deliver intervention

  At 6 months

• Participant time costs

  At 6 months

• Overhead

  At 6 months

• Amount of money provided to participants for reimbursement of trial-related expenses

  At 6 months

Other Outcomes (7)

• Proportion of patients in each arm that enroll in a clinical trial

  6 months post-baseline

• Proportion of patients in each arm retained to a clinical trial

  6 months post-baseline

• Patient trust

  6 months post-baseline

Study Arms (2)

ARM I (Clinical trial navigator, SOC)

EXPERIMENTAL

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.

Other: Best Practice; Behavioral: Patient Navigation

Arm II (SOC)

ACTIVE COMPARATOR

Patients receive SOC supportive care services.

Other: Best Practice

Interventions

Best Practice OTHER

Receive SOC supportive care services

Also known as: standard of care, standard therapy

ARM I (Clinical trial navigator, SOC); Arm II (SOC)

Patient Navigation BEHAVIORAL

Receive clinical trial navigator guide services

Also known as: Patient Navigator Program

ARM I (Clinical trial navigator, SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Andy Hill Cancer Research Endowment (CARE) Fund: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Patient Navigation

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management

Study Officials

• Jason Mendoza, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: September 23, 2024
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)