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Trial Title:
Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials
NCT ID:
NCT06484595
Condition:
Breast Carcinoma
Digestive System Carcinoma
Genitourinary System Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive SOC supportive care services
Arm group label:
ARM I (Clinical trial navigator, SOC)
Arm group label:
Arm II (SOC)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Receive clinical trial navigator guide services
Arm group label:
ARM I (Clinical trial navigator, SOC)
Other name:
Patient Navigator Program
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jean A. McDougall, PhD, MPH
Phone:
206-667-6452
Email:
jamcdoug@fredhutch.org
Investigator:
Last name:
Jason Mendoza, MD, MPH
Email:
Principal Investigator
Start date:
November 9, 2024
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Andy Hill Cancer Research Endowment (CARE) Fund
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484595
