Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials
NCT Number: NCT06484595
Acronym: GUIDE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Carcinoma|Digestive System Carcinoma|Genitourinary System Carcinoma
Interventions: OTHER: Best Practice|BEHAVIORAL: Patient Navigation
Sponsor: Fred Hutchinson Cancer Center
Collaborators: Andy Hill Cancer Research Endowment (CARE) Fund|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

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.

Primary Outcome Measures: 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 Interpersonal Physician Trust Scale., 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 measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "in General" item context as it is intended to globally reflect individuals' assessment of their health., 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) in the follow-up survey, baseline survey, and in the medical record., 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. COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients., 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. The interview guide will include questions to elicit participants perception of the intervention in terms of the acceptability, appropriateness, and feasibility within cancer care delivery., At 6 months
Secondary Outcome Measures: 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