Multilevel Connection Tool for Cancer Patients

Recruiting at 2 trial locations

Overseen By Joanna Serat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-Florida resident, others

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

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a digital tool called the ALEX Research Portal, designed to assist Black and Hispanic adult cancer patients and their families in finding and joining cancer clinical trials. The portal has two versions: a stand-alone portal with links to cancer trial resources and another that includes a virtual community health educator to guide patients. The trial seeks adults who can read at an eighth-grade level in English or Spanish, have an email or can receive texts, and live in Florida. As an unphased study, this trial provides a unique opportunity to access innovative resources that could simplify the process of finding suitable cancer trials.

Will I have to stop taking my current medications?

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

What prior data suggests that the ALEX Research Portal is safe for cancer patients?

Research shows that the ALEX Research Portal, particularly when paired with a Virtual Community Health Educator (vCHE), is safe. Studies on similar patient portals have found them helpful and safe for cancer patients managing their care, with no major reports of negative effects.

Patient portals are online tools that provide access to health information and resources, proving very helpful during cancer treatment. A virtual health educator within the portal simplifies understanding options and navigating the healthcare system.

Although specific safety data for this portal is unavailable, patient portals and digital health tools are widely used in healthcare with few safety concerns. Potential participants should know the portal is designed to support and guide, not to directly treat any medical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance how cancer patients access and understand clinical trial information. Unlike traditional methods that often leave patients to navigate complex information alone, the ALEX Research Portal offers two unique approaches. The stand-alone portal centralizes all existing resources, making it easier for patients to find what they need in one place. More uniquely, the portal with a Virtual Community Health Educator (vCHE) provides personalized guidance, allowing patients to choose from educators of diverse backgrounds who can assist them in navigating their options. This personalized digital navigation could make clinical trials more accessible and less daunting for patients, potentially increasing participation and improving patient outcomes.

What evidence suggests that the ALEX Research Portal is effective for navigating cancer patients?

Research has shown that the ALEX Research Portal, one of the tools studied in this trial, could benefit cancer patients. In this trial, some participants will use the ALEX Research Portal alone, while others will use it with a Virtual Community Health Educator (vCHE). Digital health portals like ALEX simplify access to crucial health information, such as medications and test results, helping patients manage their health more effectively. Studies have also found that guidance from a vCHE encourages patients to use these portals more effectively. This guidance is tailored to different languages and cultures, making it accessible to a broader audience. Overall, these tools can enhance cancer care by making information more accessible and personalized. ^{1 4 6 7 8}

Who Is on the Research Team?

Janice Krieger, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for Black and Hispanic adults aged 18 to 73 in Florida, who can read English or Spanish at an eighth-grade level, are willing to be re-contacted, and have email or text capabilities. It's aimed at those underrepresented in cancer clinical trials.

Inclusion Criteria

Able to read English or Spanish at least an eighth-grade level

Be a resident of the state of Florida

I can receive emails or texts.

Exclusion Criteria

Unable to read English or Spanish at least at eighth-grade level

Does not have an email account or the ability to receive texts

Unwilling to be re-contacted

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Establishment

Establish a baseline of referrals and accrual of diverse participants to CCTs across multiple Florida Center Centers

2 months

Intervention Adaptation and Pilot

Adapt and pilot the ALEX Research Portal using a randomized controlled clinical trial

2 months

Follow-up

Participants are monitored for changes in trust and self-referral rates to cancer clinical trials

2 months

Dissemination

Scale the intervention by dissemination via the OneFlorida network

What Are the Treatments Tested in This Trial?

Interventions

• ALEX Research Portal

Trial Overview The study tests a tailored ALEX Research Portal with a virtual Community Health Educator against a stand-alone portal to help guide these populations through referrals to cancer clinical trials.

How Is the Trial Designed?

Group I: Stand-alone Portal Experimental Treatment 1 Intervention

The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators.

Group II: Portal with Virtual Community Health Educator (vCHE) Experimental Treatment 1 Intervention

The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

Immune checkpoint inhibitors (ICIs) can lead to immune-related adverse events (irAEs) due to their mechanism of action, necessitating a multidisciplinary approach for effective patient management, as highlighted by 30 real-world pharmacovigilance studies.

These studies have provided valuable insights into the patterns, kinetics, and fatality rates of various irAEs, emphasizing the need for oncologists to understand both the strengths and limitations of this data for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons to be Learnt from Real-World Studies on Immune-Related Adverse Events with Checkpoint Inhibitors: A Clinical Perspective from Pharmacovigilance. Raschi, E., Gatti, M., Gelsomino, F., et al.[2021]

PCORnet is a large clinical research network that collects electronic health data from a vast array of sources, including 337 hospitals and over 80 million patients, allowing for extensive patient-centered outcomes research.

The network's infrastructure enables rapid access to diverse patient populations for conducting pragmatic clinical trials and epidemiological studies, making it a valuable resource for researching both common and rare diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PCORnet® 2020: current state, accomplishments, and future directions. Forrest, CB., McTigue, KM., Hernandez, AF., et al.[2022]

A new questionnaire was developed to measure patients' experiences of cancer care coordination, tested on 686 patients in New South Wales, Australia, and showed strong reliability and internal consistency (Cronbach's alpha 0.88).

The final instrument consists of 20 items divided into two factors, 'Communication' and 'Navigation', which effectively capture the quality of care coordination and can be used in future studies to improve cancer care services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring cancer care coordination: development and validation of a questionnaire for patients. Young, JM., Walsh, J., Butow, PN., et al.[2022]

Citations

1. withpower.com withpower.com/trial/multilevel-connection-tool-for-cancer-patients-d6fbb

Multilevel Connection Tool for Cancer Patients The ALEX Research Portal is unique because it uses a multilevel connection tool to integrate and analyze cancer patient data, potentially improving personalized ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317290/

Digital Health Portals for Individuals Living With or Beyond ... General patient portal use among cancer survivors. Access to EHRs: patients can view medications, laboratory results, visit notes, and other health data. Yes ...

3. moffitt.org moffitt.org/research-science/shared-resources/collaborative-data-services/

Collaborative Data Services The Collaborative Data Services Core (CDSC) is expressly designed to facilitate research use of patient data, leveraging Moffitt Cancer Analytics Platform ...

4. cancer.jmir.org cancer.jmir.org/2025/1/e72862/PDF

Digital Health Portals for Individuals Living With or Beyond ... This review provides an overview of digital health portal use among individuals living with or beyond cancer, encompassing both patient portals ...

5. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00260

Re-Envisioning Electronic Health Records to Optimize ... The full potential of EHRs for improving care quality, patient outcomes, surveillance, and research in cancer care is yet to be realized.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3482968/

Introduction: Understanding and Influencing Multilevel ... Efficiency may focus on the most cost-efficient use of diagnostic tools for the patient and health system as a whole. Treatment—Safety may be considered when ...

7. nature.com nature.com/articles/s43856-023-00317-6

Ensuring fair, safe, and interpretable artificial intelligence- ... We develop a computer-based tool to identify patients with cancer who are at risk of an unplanned ED visit within 30 days.

8. jons-online.com jons-online.com/issues/2019/march-2019-vol-10-no-3/2325-innovative-use-of-patient-portals-during-cancer-survivorship-a-first-step

Innovative Use of Patient Portals During Cancer Survivorship Our research offers confirmation that PPs and the Internet are viable tools to help cancer survivors during any stage of survivorship. In recent years, the ...