Clinical trial NCT06484595: Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials
Official title: Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Digestive System Carcinoma
Genitourinary System Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Andy Hill Cancer Research Endowment (CARE) Fund
name: National Cancer Institute (NCI)
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age
* Identified as potentially eligible for an open clinical trial by clinical trial pre-screening (operating in breast, gastrointestinal \[GI\], and genitourinary \[GU\] clinics)
* 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, OR unable to take time off work documented by clinical trial pre-screening (CTPS), OR
  * Medicaid insurance documented in EPIC
* 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

Primary outcomes:
measure: Proportion of patients in each arm that enroll in a clinical trial
timeFrame: 6 months post-baseline
measure: Proportion of patients in each arm retained to a clinical trial
timeFrame: 6 months post-baseline
measure: Patient trust
timeFrame: 6 months post-baseline
measure: Health related quality of life
timeFrame: 6 months post-baseline
measure: Resilience
timeFrame: 6 months post-baseline
measure: Resolution of health-related social needs
timeFrame: 6 months post-baseline
measure: Financial burden
timeFrame: 6 months post-baseline
measure: Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
timeFrame: At 6 months
Secondary outcomes:
measure: Staff time and effort to deliver intervention
timeFrame: At 6 months
measure: Participant time costs
timeFrame: At 6 months
measure: Amount of money provided to participants for reimbursement of trial-related expenses
timeFrame: At 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jason Mendoza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: