Patient Navigation for Cancer

(GUIDE Trial)

Overseen By Jean A. McDougall, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost participation and diversity in cancer clinical trials by using a "Guide" to help patients navigate potential barriers. The Guide, part of the Clinical Trial Navigation program, assists patients in understanding trial activities, identifying financial challenges, and accessing resources. It suits adults eligible for a cancer trial who face obstacles like food insecurity, housing issues, or financial worries. Participants will receive either standard care or additional help from the Guide for up to six months. As an unphased trial, this study offers a unique opportunity for patients to receive personalized support, enhancing their clinical trial experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this clinical trial navigation intervention is safe?

Research has shown that using a clinical trial navigator to assist patients is generally safe. Without physical treatment, there are no traditional side effects. Instead, the focus is on helping participants understand and manage the process of joining clinical trials. Previous studies have demonstrated that these navigation programs can help people better understand their options and make informed choices without causing harm. Participants have not reported any negative effects from the navigation itself. This program aims to clarify and simplify the process for potential trial participants, offering a different kind of support compared to medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clinical Trial Navigation approach because it offers personalized guidance for cancer patients considering clinical trials. Unlike standard supportive care, this method provides dedicated assistance in understanding the trial process, identifying financial hurdles, and accessing resources, all through regular monthly check-ins with a clinical trial navigator. This hands-on support could empower more patients to participate in clinical trials, potentially leading to better outcomes and a deeper understanding of how to make trials more accessible.

What evidence suggests that the Clinical Trial Navigation intervention is effective for increasing participation and diversity in cancer clinical trials?

Research has shown that patient navigation programs can increase participation in clinical trials. These programs assist patients in learning about trials, overcoming obstacles, and navigating the healthcare process. For example, one study found that a patient navigator made enrollment in clinical trials easier. Another study demonstrated that navigation can lead to quicker diagnosis and treatment after an unusual test result. In this trial, participants in one arm will receive support from a clinical trial navigator, potentially helping more cancer patients join and benefit from trials. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Mendoza, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for cancer patients who may face social and financial barriers to participating in clinical trials. It aims to help those with breast, gastrointestinal, or bladder cancer by providing a 'Guide' to navigate the process.

Inclusion Criteria

I was identified as a potential candidate for a clinical trial in breast, GI, or GU clinics.

Have ≥ 1 health related social need 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

Exclusion Criteria

I am under 18 years old.

Patients participating in 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers, and review available financial resources. Ongoing access to the Guide is provided for up to 6 months.

6 months

Monthly check-in meetings

Follow-up

Participants are monitored for outcomes such as trial enrollment, retention, and resolution of health-related social needs.

6 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Trial Navigation

Trial Overview The study tests a patient navigation program called GUIDE that assigns a trained navigator to assist potential participants in overcoming obstacles to join cancer clinical trials, aiming for increased diversity and inclusion.

How Is the Trial Designed?

Group I: ARM I (Clinical trial navigator, SOC) Experimental Treatment 2 Interventions

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.

Group II: Arm II (SOC) Active Control 1 Intervention

Patients receive SOC supportive care services.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Andy Hill Cancer Research Endowment (CARE) Fund

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

The Boston Patient Navigation Research Program found that patient navigation significantly reduced the time to diagnosis for women with abnormal cervical cancer screenings (adjusted hazard ratio of 1.46) and for those with breast cancer screenings that resolved after 60 days (adjusted hazard ratio of 1.40).

The study involved 4,038 women across six community health centers, highlighting the effectiveness of patient navigation in improving timely diagnosis in a diverse inner-city population, which may help reduce cancer health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening. Battaglia, TA., Bak, SM., Heeren, T., et al.[2022]

A lay navigation intervention for cancer patients significantly improved their understanding of clinical trials (CT), with pre- and post-test scores showing a notable increase (from 3.54 to 4.40, p-value 0.004).

The intervention also led to a high consent rate for CT participation, with 95% of navigated patients agreeing to enroll, indicating that lay navigators can effectively support patients in overcoming barriers to trial participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient participation in cancer clinical trials: A pilot test of lay navigation. Cartmell, KB., Bonilha, HS., Matson, T., et al.[2023]

The original patient navigation programs effectively combined community involvement and culturally sensitive care coordination to address disparities in cancer care, particularly for racial and ethnic minorities.

These programs functioned as a system rather than relying on individual navigators, with a structured team of navigators and directors working together to remove barriers and facilitate patient access to care, highlighting the importance of administrative support and community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Vargas, RB., Ryan, GW., Jackson, CA., et al.[2011]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

Patient navigation significantly enhances patients' involvement in their cancer treatment, particularly by addressing emotional and informational needs, as highlighted in interviews with 28 cancer patients.

The study emphasizes the importance of a strong partnership between patients and navigators, suggesting that emotional support and effective communication are more critical than logistical assistance in the navigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. Rousseau, SJ., Humiston, SG., Yosha, A., et al.[2021]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

In a review of 585 oncology clinical trials, 46% required interventions, highlighting a significant gap in the accuracy of trial documents that could impact patient safety.

Among the 1001 interventions identified, 17.1% were classified as potential patient safety interventions (PPSIs), primarily related to medication, indicating the need for centralized review teams to enhance safety during trial implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. Loo, VC., Kim, S., Johnson, LM., et al.[2023]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

The NAVIGATE initiative, a collaboration between the Department of Veterans Affairs and the National Cancer Institute, aims to enhance Veteran participation in cancer clinical trials by addressing recruitment challenges and establishing systematic solutions.

This initiative not only seeks to create a sustainable model for conducting oncology trials within the VA system but also focuses on increasing minority patient recruitment and developing best practices that can be shared across other VA sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Cancer Institute and Department of Veterans Affairs Interagency Group to Accelerate Trials Enrollment (NAVIGATE): A federal collaboration to improve cancer care. Schiller, SJ., Shannon, C., Brophy, MT., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317281/

Implementation of a Patient Navigation Program to Support ... Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04960787

NCT04960787 | Financial Navigation Program to Improve ... This clinical trial examines a financial navigation program in helping patients (and their spouses or partner caregivers, if participating) understand and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00375024

Study Details | NCT00375024 | Patient Navigator Project The expected outcomes of patient navigation through the cancer care system include: Timely, definitive diagnosis following an abnormal test; Timely treatment ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6197623/

Patient navigation and clinical trial participation This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into ...

5. withpower.com withpower.com/trial/phase-breast-neoplasms-8-2024-2c7fa

Patient Navigation for Cancer (GUIDE Trial) This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials.

6. aaci-cancer.org aaci-cancer.org/Files/Admin/CRI/2025/85-Abstract-Implementation-of-a-Patient-Navigation-Program-to-Increase-Representative-Enrollment.pdf

Completed project Implementation of a Patient Navigation ... To our knowledge, this is the first program to provide and evaluate clinical trial navigation across cancer types, populations, and clinical settings.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT04960787

Financial Navigation Program to Improve Understanding ... This clinical trial examines a financial navigation program in helping patients understand and better manage the financial aspects of cancer care.