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 (8)

• 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

• 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

• 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

• 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

• 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

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: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)