Patient Navigation Program for Cancer Trial Enrollment

Overseen By Yasser Ged, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Age < 18, No solid tumor, 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 explores how varying levels of support can assist cancer patients in joining clinical trials. It compares a high-intensity navigation approach, which includes personal meetings and a needs assessment, to a low-intensity approach that involves only educational materials and brief reviews. The focus is on patients with prostate or kidney cancer who are already receiving care at specific cancer centers and have a trial available to them. The study aims to determine which type of support facilitates patient participation in cancer research. As an unphased trial, it offers patients the opportunity to contribute to research that could enhance support systems for future cancer patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this patient navigation program is safe for improving cancer trial enrollment?

Research has shown that patient navigation programs are safe and beneficial for cancer care. These programs guide and support patients through the healthcare system, improving cancer screening rates, helping patients adhere to their treatment plans, and increasing overall satisfaction with care.

By providing educational materials and personal support, these programs are not expected to cause harm. Instead, they act as a bridge, helping patients access the care they need. Studies have not reported any safety concerns related to these programs.

These trials focus on how different levels of patient support might influence the decision to join a cancer trial, not on testing new medications or treatments. Therefore, the navigation process itself poses no safety risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how different levels of patient support can improve cancer trial enrollment. Unlike traditional approaches that may leave patients to navigate the complexities of clinical trials on their own, this trial is testing a "high intensity" support system. This involves personalized guidance from patient navigators to help address any barriers to trial participation. The goal is to see if this tailored support can lead to more patients taking part in potentially life-saving clinical trials, providing a more patient-centric approach to cancer care.

What evidence suggests that this patient navigation program is effective for improving cancer trial enrollment?

Research has shown that patient navigation programs can significantly increase the number of cancer patients enrolling in clinical trials. In this trial, participants will receive either a high-intensity or low-intensity approach. Early results suggest that the high-intensity approach, which involves detailed assistance and obstacle identification, significantly boosts participation. Conversely, the low-intensity approach offers valuable support by providing key information and resources to encourage trial involvement. Both methods aim to remove barriers and offer meaningful support, facilitating easier participation in clinical trials. ^{1 2 3 4 6}

Who Is on the Research Team?

Yasser Ged, MBBS

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

This trial is for adults over 18 with prostate or kidney cancer, being treated at the Sidney Kimmel Comprehensive Cancer Center or Wellspan Health Center. They must have a solid tumor diagnosis and an available therapeutic trial determined through pre-screening.

Inclusion Criteria

Being seen at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) or Wellspan Health Center

I have been diagnosed with either prostate or kidney cancer.

The patient has other treatment options available through pre-screening or medical records.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Patient Navigation

Participants are randomly assigned to either high intensity or low intensity patient navigation programs. High intensity involves a needs assessment and addressing barriers to trial participation.

18 months

Regular meetings with patient navigator

Follow-up

Participants are monitored for enrollment and retention rates in clinical trials

18 months

What Are the Treatments Tested in This Trial?

Interventions

• High intensity approach
• Low intensity approach

Trial Overview The study tests two types of patient navigation programs to see which one better helps patients enroll in cancer trials. One group will receive high intensity navigation support, while the other gets low intensity support, assigned randomly.

How Is the Trial Designed?

Group I: High Intensity Approach Experimental Treatment 1 Intervention

Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation, cancer center support services; and community resources and services available to cancer patients. The PEM will be reviewed by the clinical trial patient navigator with the patient prior to the clinic visit with the medical oncologist. If the patient is offered participation in a therapeutic clinical trial, the high intensity patient navigation begins. The patient navigator will arrange to meet with the patient to complete a needs assessment to identify and address barriers to trial participation within one week of the visit with the medical oncologist (and clinical trial offer).

Group II: Low Intensity Approach Active Control 1 Intervention

Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation and community resources and services available to cancer patients. The PEM will be reviewed by the patient navigator with the patient prior to the clinic visit with the medical oncologist.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

WellSpan Health

Collaborator

Trials

32

Recruited

2,005,000+

Published Research Related to This Trial

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]

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]

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]

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]

In a study involving 10,521 participants with abnormal cancer screenings and 2,105 with cancer diagnoses, patient navigation significantly improved the timeliness of diagnostic resolution and treatment initiation after 90 days, with adjusted hazard ratios of 1.51 and 1.43, respectively.

The effectiveness of patient navigation was particularly notable in centers where there were greater delays in follow-up care, suggesting that this intervention is especially beneficial for populations at risk of being lost to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. Freund, KM., Battaglia, TA., Calhoun, E., et al.[2022]

Patient navigation significantly improves participation in cancer screening and reduces the time from screening to diagnosis and from diagnosis to treatment initiation, based on a review of 61 systematic reviews and 53 primary studies.

Emerging evidence indicates that patient navigation enhances quality of life and patient satisfaction during survivorship, while also reducing hospital readmissions during active treatment and survivorship phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation across the cancer care continuum: An overview of systematic reviews and emerging literature. Chan, RJ., Milch, VE., Crawford-Williams, F., et al.[2023]

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]

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]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06138067

Patient Navigation Program to Improve Clinical Trial ... The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in ...

2. 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 ...

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

Implementation of a Patient Navigation Program to Support ... Navigation programs increase cancer screening rates, treatment adherence, quality of life, and satisfaction with care, improve cancer outcomes, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213538321000369

Accelerating cancer clinical trial recruitment through a ... This study observed that the IMPACT intervention accelerated clinical trial recruitment, especially among late phase clinical trials.

5. rapidtrials.com rapidtrials.com/improving-cancer-care-the-impact-of-patient-navigation-on-clinical-trial-enrollment/

Improving Cancer Care with Patient Navigation in Trials Initial results suggest that high-intensity patient navigation has a significant impact on clinical trial enrollment. This approach helps ...

6. 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 ...