SUPPORT Toolkit for Cancer

Overseen By Elyse R Park, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Non-oncology patients, Non-NCORP sites, others

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a new SUPPORT toolkit (a set of educational and guidance resources) can increase the number of Black and Latino cancer patients joining clinical trials. The toolkit combines guidance from clinical trial navigators with educational tools to boost awareness and understanding of trials. Participants will either receive the toolkit or continue with their usual care to determine which approach is more effective. Ideal candidates are Black or Latino cancer patients receiving treatment at a participating community oncology site who qualify for a specific type of clinical trial. As an unphased trial, this study offers a unique opportunity to contribute to research that may improve clinical trial access and participation for underrepresented communities.

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

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

What prior data suggests that the SUPPORT toolkit is safe?

Research has shown that the SUPPORT toolkit, which includes guides and resources for understanding clinical trials, is generally safe to use. As it is neither a drug nor a medical device, it lacks the usual risks associated with medications. Instead, it aims to help cancer patients learn about and access clinical trials more easily.

Since this toolkit emphasizes education and support, similar tools have not reported serious risks or negative effects in the past. Its primary goal is to improve understanding and access, which typically involves very little risk for participants.

This trial is in a "not applicable" phase, focusing on methods rather than testing new drugs or devices. This suggests minimal safety concerns, as the toolkit is intended to assist rather than directly treat cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SUPPORT toolkit is unique because it focuses on enhancing the overall care experience for cancer patients rather than just targeting the cancer itself. Unlike traditional treatments that primarily aim at eliminating cancer cells through methods like chemotherapy or radiation, the SUPPORT toolkit provides resources and interventions designed to improve patient wellbeing and support. Researchers are excited about this approach because it addresses the emotional and psychological aspects of cancer care, which can significantly impact a patient's quality of life and treatment outcomes. By integrating comprehensive support into the care plan, this toolkit has the potential to complement existing medical treatments and lead to better holistic care for cancer patients.

What evidence suggests that the SUPPORT toolkit is effective for improving cancer patient referral and accrual to clinical trials?

Research has shown that tools like the SUPPORT toolkit, which participants in this trial may receive, can improve cancer care. These toolkits are designed for ease of use, helping patients and healthcare providers better understand cancer treatment options. The Patient Navigation Barriers and Outcomes Tool (PN-BOTTM) has effectively managed and reported cancer care information. Additionally, the Stronger Together Toolkit has provided support and resources tailored to different cultures. These toolkits aim to increase patient knowledge and involvement, enhancing cancer treatment experiences, especially for Black and Latino patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Melissa A Simon, MD, MPH

Principal Investigator

Eastern Cooperative Oncology Group

Are You a Good Fit for This Trial?

This trial is for Black and Latino cancer patients over 18 years old who are treated at NCORP community oncology sites, speak English or Spanish, have access to technology for communication, and can sign an e-consent. They must be eligible for ECOG-ACRIN clinical trials.

Inclusion Criteria

Participant must self-identify as Black and/or Latino

Participant must be an oncology patient at a participating NCORP

Participant must be eligible to participate in an ECOG-ACRIN clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the EA SUPPORT intervention combining CT navigators and CT research literacy tools

12 months

Follow-up

Participants are monitored for changes in CT awareness and knowledge, and referral and accrual outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• SUPPORT toolkit

Trial Overview The SUPPORT toolkit intervention is being tested to see if it helps increase the number of Black and Latino patients referred to and participating in NCI-supported cancer clinical trials. It includes CT navigators and research literacy tools.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participant will receive intervention and receive the SUPPORT toolkit.

Group II: Control Active Control 1 Intervention

Participant will receive usual care

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Published Research Related to This Trial

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]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A machine-learning model was developed using data from 4638 patients across 16 FDA-approved small molecule kinase inhibitors (SMKIs) to analyze the relationship between kinase targets and adverse events (AEs), providing a new tool for predicting safety risks in cancer treatments.

The model not only helps identify potential kinase-inhibitor adverse event pairs but also serves as a precision medicine tool to enhance patient safety by forecasting clinical safety signals and aiding in the development of safer SMKI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decoding kinase-adverse event associations for small molecule kinase inhibitors. Gong, X., Hu, M., Liu, J., et al.[2022]

A new oncology-focused trigger tool has been developed to systematically assess adverse drug events (ADEs) in cancer care, validated by a panel of 30 pharmacists and practitioners across nine hospitals in France.

The tool includes a standardized list of 15 specific ADEs, along with criteria for evaluating causality, severity, and preventability, making it a practical resource for monitoring and improving patient safety in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology. Hébert, G., Netzer, F., Kouakou, SL., et al.[2018]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10086624/

The PhenX Toolkit: standard measurement resources for ... This brief report introduces the Cancer Outcomes and Survivorship domain in the PhenX Toolkit (consensus measures for Phenotypes and eXposures), ...

2. fredhutch.org fredhutch.org/en/news/spotlight/2023/05/cc-ramsey-mdmpp.html

A user-friendly toolkit for cancer control planning Engaging user centered design principles can improve cancer survivorship economic analysis tools for end users.

3. cancercontroltap.org cancercontroltap.org/resources/gw-tools-and-resources/

GW Tools and Resources The Patient Navigation Barriers and Outcomes Tool (PN-BOTTM) is a free, Excel-based data entry, data management and reporting product designed for oncology ...

4. ascopubs.org ascopubs.org/doi/10.1200/GO.22.21000

Stronger Together Toolkit: An Open Resource to Implement ... The “Stronger Together Toolkit” (STT) is an open-source, self-guided peer support program that allows for the provision of cultural and resource adaptation.

5. nccrt.org nccrt.org/resource/evaluation-toolkit/

Evaluation Toolkit: How to Evaluate Activities to Increase ... The toolkit will help you learn the seven basic steps to evaluation, whether you are working to increase community demand for colorectal cancer screening.

6. cancer.org cancer.org/cancer/preparing-for-treatment/cancer-care-toolkit.html

Cancer Care Toolkit Choose from this collection of worksheets to help you stay organized. Keep track of your appointments, medications, and test results all in one place. Print the ...

7. capc.org capc.org/toolkits/palliative-care-in-cancer-care/

Palliative Care in Cancer Care - Tools for Oncologists This toolkit contains clinical training for conducting effective conversations about treatment goals, managing pain and other symptoms, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6563614/

A Systematic Review of Clinical Decision Support Systems for ... We performed a systematic review of peer-reviewed studies evaluating outcomes of electronic CDS systems for cancer diagnosis, treatment, and supportive care.

9. media.cancercare.org media.cancercare.org/publications/original/447-CancerCare-EmployeeProtection-Toolkit-digital.pdf

Employee Protection Toolkit: This Toolkit is designed to help explain the unintended consequences of increasingly common prescription drug cost control measures and offer ...

10. all-can.org all-can.org/wp-content/uploads/2024/09/AllCanActionGuide24-1.2.7.pdf

Action Guide For Efficient Cancer Care Cancer registries are regularly updated and, if they include staging information, they can facilitate the monitoring of access, quality of care, and outcomes. • ...