What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include surgery, chemotherapy, and radiation therapy. Surgery can lead to complications such as infections, bleeding, and bowel dysfunction. Chemotherapy often causes side effects like nausea, vomiting, diarrhea, fatigue, and an increased risk of infections due to lowered white blood cell counts. Radiation therapy can result in skin irritation, fatigue, and gastrointestinal issues such as diarrhea and rectal bleeding. These treatments aim to manage and eradicate cancer but come with significant side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of colorectal cancer, including chemotherapeutic agents like 5-fluorouracil (5-FU), oxaliplatin, and irinotecan, as well as targeted therapies such as bevacizumab, cetuximab, and panitumumab. These treatments are typically used in various combinations depending on the stage and genetic profile of the cancer. While these drugs are crucial for treatment, the Hub-and-Spoke Model focuses more on early detection and follow-up care, which involves the use of FIT kits for initial screening and colonoscopies for those with abnormal results. This model aims to improve CRC outcomes by ensuring timely and effective follow-up and referral to care.

What other types of research exist?

Promising, novel alternatives to the Hub-and-Spoke Model for CRC screening, follow-up, and referral-to-care include: 1) Telemedicine platforms for remote consultations and follow-ups, enhancing accessibility for underserved populations. 2) AI-driven predictive analytics to identify high-risk individuals and personalize screening schedules. 3) Mobile health units that bring screening services directly to communities, increasing reach and convenience. 4) Community-based participatory research to engage local populations in designing and implementing screening programs. 5) Personalized medicine approaches that tailor screening and treatment plans based on genetic and molecular profiling of patients.

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Colorectal Cancer Screening for Colorectal Cancer

Phase 3

Waitlist Available

Led By Maria E Martinez

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

50 - 75 years old

Be older than 18 years old

Must not have

Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to improve colorectal cancer screening among underserved populations by mailing out test kits and reminders. The goal is to increase the number of people who complete the screening and follow-up tests. Fecal immunochemical tests (FITs) have been shown to be effective in increasing colorectal cancer screening rates, especially when combined with mailed reminders.

Who is the study for?

This trial is for individuals aged 50-75 in San Diego or Riverside Counties who are insured, have had an office visit within the last year, and are not up to date with colorectal cancer screening. They must have a valid address and phone number. Those without insurance, a valid contact method, or with past colorectal surgery/cancer are excluded.

What is being tested?

The study tests whether mailing FIT kits for at-home testing and providing follow-up navigation can increase colonoscopy completion rates among those who need it. Participants will be randomly assigned to receive these interventions or usual care to compare effectiveness.

What are the potential side effects?

There may not be direct side effects from participating since this trial involves mailed outreach and navigation rather than medical treatments. However, stress or discomfort related to completing the FIT test and potential subsequent procedures could occur.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 50 and 75 years old.

Exclusion Criteria

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

Select...

I have had my entire colon removed or have been diagnosed with colorectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of abnormal fit results until the date of colonoscopy completion, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of abnormal fit results until the date of colonoscopy completion, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of abnormal fit results until the date of colonoscopy completion, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Colonoscopy after abnormal FIT (primary)

Screening up-to-date (primary)

Secondary study objectives

FIT Completion

Follow-up process

Time to colonoscopy after abnormal FIT

Other study objectives

Repeat screening (exploratory outcome)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mailed FIT OutreachExperimental Treatment2 Interventions

Primer, FIT Kit, Reminders, Abnormal FIT Follow-up

Group II: Usual CareActive Control1 Intervention

0 / 2Eligibility 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

Common treatments for colorectal cancer (CRC) include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy, such as fluorouracil and oxaliplatin, works by interfering with DNA replication in rapidly dividing cancer cells, leading to cell death. Radiation therapy uses high-energy rays to damage the DNA of cancer cells, inhibiting their ability to grow and divide. Targeted therapies, like cetuximab, focus on specific molecular targets such as the epidermal growth factor receptor (EGFR), blocking signals that promote cancer cell growth. These treatments are crucial for CRC patients as they aim to reduce tumor size, prevent metastasis, and improve survival rates. The Hub-and-Spoke Model's emphasis on centralized strategies for screening, follow-up, and referral-to-care ensures timely and effective treatment, which is vital for improving patient outcomes.

Developing a model of a patient-group pathway to accessing cancer clinical trials in Canada.