Clinical trial · Interventional
Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials
Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Patient Navigation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM I (Clinical trial navigator, SOC)
- description
- 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 via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services.
- interventionNames
- Other: Best Practice
- Behavioral: Patient Navigation
- type
- ACTIVE_COMPARATOR
- label
- Arm II (SOC)
- description
- Patients receive SOC supportive care services.
- interventionNames
- Other: Best Practice
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available