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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to pilot test and evaluate an existing tailored ALEX Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical 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 data supports the effectiveness of the treatment ALEX Research Portal for cancer patients?

Patient-reported outcome tools, when integrated into electronic medical records, have shown clinical benefits like improved overall survival for cancer patients, suggesting that similar tools like the ALEX Research Portal could be effective in enhancing cancer care. ^{1 2 3 4 5}

What safety data exists for the Multilevel Connection Tool for Cancer Patients?

The research articles discuss various tools and methods for identifying and reporting adverse events (side effects) in cancer treatments, but they do not provide specific safety data for the Multilevel Connection Tool for Cancer Patients or its other names. ^{6 7 8 9 10}

How is the ALEX Research Portal treatment unique 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 treatment plans by leveraging a robust semantic framework and federated data analysis from multiple sources. ^{11 12 13 14 15}

Research Team

Janice Krieger, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am between 18 and 100 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Variation in Integrated Head and Neck Cancer Care: Impact of Patient and Hospital Characteristics. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

PCORnet® 2020: current state, accomplishments, and future directions. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Measuring cancer care coordination: development and validation of a questionnaire for patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes Integrated Within an Electronic Medical Record in Patients With Head and Neck Cancer. [2021]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Towards precision informatics of pharmacovigilance: OAE-CTCAE mapping and OAE-based representation and analysis of adverse events in patients treated with cancer drugs. [2019]

10. France 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Challenges in Using a Graph Database to Represent and Analyze Mappings of Cancer Study Data Standards. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Mapping the Oncological Basis Dataset to the Standardized Vocabularies of a Common Data Model: A Feasibility Study. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Profile of the multicenter cohort of the German Cancer Consortium's Clinical Communication Platform. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Cancer Research Line (CAREL): Development of Expanded Distributed Research Networks for Prostate Cancer and Lung Cancer. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Cancer registry databases: an overview of techniques of statistical analysis and impact on cancer epidemiology. [2008]