SURGE Support Program for Cancer Trial Enrollment

Recruiting at 2 trial locations

Overseen By Nadine J McCleary, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nadine McCleary, MD, MPH

Disqualifiers: Surveillance-only malignancy, Non-DFCI care, Language, Consent, others

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

Compensation: Varies

Number of Visits: Unknown

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help underrepresented cancer patients understand and agree to genomic testing by providing a guide, sending text message questions, and showing an informational video. The goal is to make it easier for these patients to access personalized treatments and clinical trials. By addressing their educational and social needs, the intervention supports better decision-making about their care.

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 safety data exists for the SURGE treatment in humans?

The research highlights the importance of monitoring adverse events (side effects) in clinical trials to ensure patient safety. This includes real-time systems for quality assurance and centralized reviews of serious adverse events, which help ensure that participants are not exposed to avoidable risks. ^{1 2 3 4 5}

Research Team

Nadine J. McCleary, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

The SURGE trial is for adults over 18 with advanced gastrointestinal, blood, or lung cancer. It's focused on helping underrepresented groups like Black, Latinx, American Indian, Pacific Islander individuals, those with limited English proficiency in Spanish, older adults (70+), and people from low-income areas or facing social challenges.

Inclusion Criteria

My cancer is in the stomach, blood, or chest area.

DFCI patient at Longwood/Chestnut Hill, DFCI satellite at St. Elizabeth's Medical Center, or DFCI satellite at Merrimack Valley

I am 18 years old or older.

Exclusion Criteria

I am unable to give my consent for participation.

My cancer only needs regular monitoring.

Not continuing care at a participating DFCI site

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

Screening questionnaire via text or phone

Intervention

Participants receive the SURGE intervention, which includes an informational video and/or patient navigation

Up to 90 days

Intervention delivery via video and/or patient navigation

Follow-up

Participants are monitored for genomic testing uptake and interaction with the intervention

Up to 90 days

Treatment Details

Interventions

• SURGE

Trial Overview SURGE tests a support system to help these patients join genomic-based cancer trials. The intervention includes a personal guide (navigator), text message surveys, and an educational video to overcome barriers to precision therapy access.

Participant Groups

Group I: Arm C (informational video and patient navigation) Experimental Treatment 1 Intervention

Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video and Patient Navigation

Group II: Arm B (informational video) Experimental Treatment 1 Intervention

Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video

Group III: Arm A (standard of care) Active Control 1 Intervention

Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: * Standard of Care

Who Is Running the Clinical Trial?

Nadine McCleary, MD, MPH

Lead Sponsor

Trials

1

Recruited

210+

Nadine McCleary MD, MPH

Lead Sponsor

Trials

1

Recruited

210+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a review of 179 cancer surgery trial reports, only 31.3% focused on morbidity assessment, highlighting a lack of emphasis on adverse event (AE) reporting in these studies.

Only 8.3% of studies provided detailed reporting of AEs by event and grade, indicating a significant need for improvement in how AEs are documented and defined in cancer surgery trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients. Meghelli, L., Narducci, F., Mariette, C., et al.[2018]

Data and safety monitoring plans are crucial in clinical trials to ensure patient safety and to provide transparency about risks, helping participants make informed decisions about their involvement.

These plans involve independent oversight, regular data collection, and active surveillance for adverse events, ensuring that any potential risks are managed effectively throughout all phases of the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating and implementing data and safety monitoring plans. Terrin, ML.[2016]

In a study of 4,158 metastatic colorectal cancer patients, the most expensive adverse events (AEs) associated with treatment were hematologic issues, costing an average of $1,480 per month, followed by respiratory and endocrine/metabolic AEs.

The research highlights that these AEs significantly increase healthcare costs during treatment episodes, emphasizing the need for effective management strategies to minimize their impact on patient care and healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States. Latremouille-Viau, D., Chang, J., Guerin, A., et al.[2017]

A comprehensive final review of patient records in four phase III NSABP cancer trials involving 7972 participants found only minor discrepancies, such as seven additional cases of ineligibility, suggesting that existing quality assurance systems are largely effective.

The review was resource-intensive and did not significantly enhance the integrity of the database, indicating that routine final comprehensive chart reviews may not be necessary in well-monitored trials like those conducted by NSABP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Soran, A., Nesbitt, L., Mamounas, EP., et al.[2006]

In a study of 881 patients aged 65 and older with metastatic renal cell carcinoma (mRCC), 60% experienced adverse events (AEs) related to targeted therapies, leading to significantly higher healthcare costs.

Patients with AEs incurred an average cost of $13,944 over 30 days, compared to just $1,878 for those without AEs, highlighting the financial impact of managing these toxicities and suggesting that better management could reduce overall healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic burden of selected adverse events in patients aged ≥65 years with metastatic renal cell carcinoma. Hagiwara, M., Hackshaw, MD., Oster, G.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating and implementing data and safety monitoring plans. [2016]

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

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Economic burden of selected adverse events in patients aged ≥65 years with metastatic renal cell carcinoma. [2018]