SUPPORT Toolkit for Cancer

Overseen By Elyse R Park, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eastern Cooperative Oncology Group

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in NCORP community oncology practice sites (N= 500 Black and Latino cancer patients) to evaluate the effectiveness of the EA SUPPORT intervention combining CT navigators and CT research literacy tools in improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the CUSP2CT data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks.

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 data supports the effectiveness of the SUPPORT toolkit treatment for cancer?

Research indicates that using patient-reported outcomes (PROs) in cancer care, which is a component of the SUPPORT toolkit, can improve patient management by addressing issues like anxiety, depression, and unmet needs. Studies show that feedback from PROs to clinicians can lead to better patient functioning and care processes. ^{1 2 3 4 5}

Is the SUPPORT Toolkit for Cancer safe for humans?

The articles reviewed focus on safety tools and methods for identifying adverse events in cancer treatments, but they do not provide specific safety data for the SUPPORT Toolkit for Cancer. However, they emphasize the importance of monitoring and assessing adverse events to ensure patient safety in oncology. ^{6 7 8 9 10}

Research Team

Melissa A Simon, MD, MPH

Principal Investigator

Eastern Cooperative Oncology Group

Eligibility Criteria

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 be receiving care at a participating NCORP affiliated community oncology site

Participant must self-identify as Black and/or Latino

Participant must be an oncology patient at a participating NCORP

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States 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. [2022]

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

What can I do? Recommendations for responding to issues identified by patient-reported outcomes assessments used in clinical practice. [2022]

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

Bringing PROMIS to practice: brief and precise symptom screening in ambulatory cancer care. [2022]

4. Germany 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Stepping into the real world: a mixed-methods evaluation of the implementation of electronic patient reported outcomes in routine lung cancer care. [2022]

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

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

7. England 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. [2021]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Decoding kinase-adverse event associations for small molecule kinase inhibitors. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology. [2018]