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

Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Best Practice; Behavioral: Patient Navigation

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Best Practice; Receive SOC supportive care services; Other Names: standard of care; standard therapy; Behavioral: Patient Navigation; Receive clinical trial navigator guide services; Other Names: Patient Navigator Program
Active Comparator: Arm II (SOC); Patients receive SOC supportive care services.	Other: Best Practice; Receive SOC supportive care services; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff time and effort to deliver intervention	This is the time spent by the Guide with patients, preparing for patient visits, and delivering the intervention.	At 6 months
Participant time costs	This is the time spent by patients on all activities related to the cancer clinical trial and with the Guide.	At 6 months
Amount of money provided to participants for reimbursement of trial-related expenses	The amount of money provided to participants for reimbursement of trial-related expenses.	At 6 months
Overhead	Overhead costs are defined as the indirect expenses associated with delivering the GUIDE intervention. This includes the facility costs, measured using the facilities and administration rate, as well as non-clinical equipment and supplies needed to deliver the intervention. Observation-based costs accrued over the intervention delivery period will be averaged and standardized to US 2024 dollars.	At 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in each arm that enroll in a clinical trial	Will use descriptive statistics to characterize and compare by pilot trial arm all patients enrolled versus not enrolled in clinical trials. Will be comparing X% of individuals enrolled in a cancer clinical trial (x/50) in the intervention arm and Y% of individuals enrolled in a cancer clinical trial (y/50) in the usual care arm. Information about trial enrollment and retention at 6 months will be abstracted from Online Collaborative Research Environment (OnCore) Clinical Management System.	6 months post-baseline
Proportion of patients in each arm retained to a clinical trial	Will use descriptive statistics to characterize and compare by pilot trial arm all patients retained versus not retained in clinical trials. Assessment of trial retention will be restricted to the denominator of patients who enroll in a cancer clinical trial. Information about trial enrollment and retention at 6 months will be abstracted from OnCore Clinical Management System.	6 months post-baseline
Resilience	Will be assessed using the Brief Connor-Davidson Resilience Scale to assess the ability to recover or bounce back from stress.	6 months post-baseline
Patient trust	Will be measured by the 12-item Trust in Medical Researchers scale. Each item will be answered on a 5-point Likert scale and scored accordingly (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree).	6 months post-baseline
Health related quality of life	Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score. The PROMIS Global Health instruments generate scores that are converted to T-scores, with a mean of 50 and a standard deviation of 10 in the US general population, allowing for comparison to a reference group. Higher T-scores indicate better health outcomes.	6 months post-baseline
Resolution of health-related social needs	Will be measured by comparing the responses to the Health Related Social Needs (HRSN) questions (food insecurity, housing instability, transportation challenges, financial distress).	6 months post-baseline
Financial burden	Will be measured from the patient perspective using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity (FACIT-COST) scale. FACIT-COST Includes 12 items with responses on a 5-point Likert type scale. The maximum and minimum total scores range from 0-44 with higher scores representing better financial wellbeing.	6 months post-baseline

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); Andy Hill Cancer Research Endowment (CARE) Fund
• Investigators: Principal Investigator: Jason Mendoza, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Standard of Care; Practice Guidelines as Topic; Patient Navigation
• Other Study ID Numbers: RG1124291; P30CA015704 (U.S. NIH Grant/Contract); NCI-2024-04530 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No