What side effects are associated with this type of intervention?

Common treatments for colon cancer, such as adjuvant chemotherapy with fluorouracil plus leucovorin, can lead to side effects including neutropenia, gastrointestinal issues like diarrhea and constipation, and peripheral neuropathy. Prehabilitation programs, like the one studied in the PrehabPal trial, aim to improve patients' physical and psychological readiness for surgery, potentially mitigating some of these side effects by enhancing overall fitness and resilience.

What prior FDA approvals exist?

FDA-approved treatments for colon cancer include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. Commonly used chemotherapeutic agents include 5-fluorouracil (5-FU), oxaliplatin, and irinotecan. Targeted therapies such as bevacizumab, cetuximab, and panitumumab have also been approved for use in specific genetic profiles of colon cancer. Immunotherapy options include pembrolizumab and nivolumab for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments can be part of a comprehensive care plan that includes surgery, which is the focus of the PrehabPal web app's prehabilitation program.

What other types of research exist?

Promising alternatives to the PrehabPal web app for colon cancer patients include the SurvivorCHESS program, which is an eHealth intervention designed to increase physical activity and improve quality of life and distress in colon cancer survivors. Additionally, digital health interventions like physical activity trackers and text message-based programs, as studied in the Smart Pace II trial for colorectal cancer patients during chemotherapy, may also be considered.

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PrehabPal Digital Tool for Surgery Preparation in Colorectal Cancer

N/A

Recruiting

Led By Emily Finlayson, MD, MS, FACS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the PrehabPal web app to see if it better helps people aged 65 and older prepare for colon cancer surgery. The app offers personalized exercise plans and coaching to improve their readiness and recovery. Prehabilitation has experienced significant growth in the field of colon cancer treatment for elderly patients.

Who is the study for?

This trial is for individuals aged 65 or older who are preparing for colorectal cancer surgery and have at least a week before their operation. They must be able to understand English, provide consent, and have internet access. Those with dementia, Alzheimer's disease, surgeries within 7 days, or conditions that risk safety/data quality cannot participate.

What is being tested?

The study compares the PrehabPal web app against written instructions for pre-surgery preparation in older adults facing colon cancer surgery. The aim is to see if PrehabPal can better individualize prehabilitation programs and offer coaching support.

What are the potential side effects?

Since PrehabPal is a digital tool rather than a medication, traditional side effects are not expected. However, users may experience difficulty using the app or frustration if technical issues arise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days following surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Operative Surgical Procedures

Secondary study objectives

Change in Mean score on the SF-36

Median Length of Stay (LOS)

Proportion of participants with reported Surgical Complications

+1 more

Other study objectives

Median Satisfaction Scores

Awards & Highlights

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: PrehabPal Web appExperimental Treatment1 Intervention

Web app based initial geriatric assessment will be given followed by daily tailored prehabilitation activities in the domains of exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. Each participant is paired with a central health coach who monitors engagement and provides support through the Web app portal.

Group II: Written Surgery Prehabilitation InstructionsActive Control1 Intervention

Participants will be provided paper-based prehabilitation instructions that include information about exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. A paper diary is provided to record any prehabilitation activities.

Do I qualify?Apply below to find out

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 colon cancer include surgery, chemotherapy, and radiation therapy. Surgery involves physically removing the tumor and is often the first line of treatment. Chemotherapy uses drugs to kill cancer cells or stop them from growing, with agents like 5-fluorouracil (5-FU) and oxaliplatin being commonly used. Radiation therapy uses high-energy rays to target and kill cancer cells. The PrehabPal web app emphasizes individualized prehabilitation programs and coaching, which aim to improve patients' physical and mental health before surgery. This can enhance recovery, reduce complications, and improve overall outcomes by optimizing the patient's condition prior to undergoing invasive treatments.

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