Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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.
Interventions
OTHERBest Practice
Receive SOC supportive care services
BEHAVIORALPatient Navigation
Receive clinical trial navigator guide services
Sponsors
Fred Hutchinson Cancer Center
Andy Hill Cancer Research Endowment (CARE) Fund
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant perceptions of the intervention (acceptability, appropriateness, feasibility) | At 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff time and effort to deliver intervention | At 6 months | This is the time spent by the Guide with patients, preparing for patient visits, and delivering the intervention. |
| Participant time costs | At 6 months | This is the time spent by patients on all activities related to the cancer clinical trial and with the Guide. |
| Overhead | At 6 months | 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. |
| Amount of money provided to participants for reimbursement of trial-related expenses | At 6 months | The amount of money provided to participants for reimbursement of trial-related expenses. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Mendoza, MD, MPH
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed