What side effects are associated with this type of intervention?

Common treatments for gastrointestinal cancer include surgery, chemotherapy, and radiation therapy. Surgery can lead to bowel symptoms such as constipation, incomplete emptying, and fecal incontinence. Chemotherapy often causes side effects like nausea, vomiting, diarrhea, and fatigue. Radiation therapy can result in acute and chronic gastrointestinal toxicities, including proctitis, enteritis, and diarrhea. The trial involving a patient navigator, text message questionnaire, and informational video aims to provide guidance, gather information, and educate patients to better manage these side effects.

What prior FDA approvals exist?

FDA-approved treatments for gastrointestinal cancer include pembrolizumab and nivolumab, which are immune checkpoint inhibitors used for advanced or metastatic cases. Pembrolizumab is approved for tumors with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB) that have progressed after prior treatment. Nivolumab is approved for advanced squamous cell carcinoma (SCC) of the esophagus after prior chemotherapy. These treatments, while primarily pharmacological, can be complemented by supportive interventions like patient navigation, text message questionnaires, and informational videos to enhance patient education and engagement, similar to the approach studied in the SURGE trial.

What other types of research exist?

Promising, novel alternatives for gastrointestinal cancer patients considering treatment in 2024 include: 1) AI-driven chatbots for personalized patient support and information dissemination, 2) Virtual reality (VR) platforms for patient education and pre-treatment simulations, 3) Mobile health apps with integrated telemedicine features for continuous monitoring and communication with healthcare providers, and 4) Wearable devices that track health metrics and provide real-time data to both patients and clinicians.

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Behavioral Intervention

SURGE Support Program for Cancer Trial Enrollment

N/A

Recruiting

Led By Nadine J McCleary, MD MPH

Research Sponsored by Nadine McCleary, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gastrointestinal, hematologic, or thoracic cancer

Adult (age 18 years or older)

Must not have

Unable to provide consent

Malignancy or former malignancy that requires only surveillance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days of enrollment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since SURGE is not testing a drug but an intervention program aimed at improving trial enrollment processes through education and navigation services, there are no direct medical side effects associated with typical clinical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I have an advanced cancer that needs treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give my consent for participation.

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My cancer only needs regular monitoring.

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I speak a language that is not English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Genomic testing uptake

Secondary study objectives

Acceptability of questionnaire modality

Patient interaction with the intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (informational video and patient navigation)Experimental Treatment1 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 Treatment1 Intervention

Group III: Arm A (standard of care)Active Control1 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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for gastrointestinal cancer include chemotherapy, which works by killing rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in cancer growth and progression; and immunotherapy, which enhances the body's immune system to fight cancer. These treatments are crucial for managing gastrointestinal cancer as they can significantly improve survival rates and quality of life. The SURGE trial's approach of using a patient navigator, text message questionnaire, and informational video underscores the importance of patient education and guidance in ensuring patients understand their treatment options and can access the most appropriate therapies.

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