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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
100
Receive SOC supportive care services
Receive clinical trial navigator guide services
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
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.
Time frame: At 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 6 months
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