Medical and Psychosocial Issues for Colorectal Cancer

Not currently recruiting at 1 trial location

Overseen By Charlean Ketchens, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Life expectancy < 6 months, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how colorectal cancer impacts the daily lives of adolescents and young adults, both physically and mentally. Researchers aim to understand how well young people with this cancer can function physically during treatment and how to improve their care management. The study may also aid in developing a future exercise program (also known as a physical therapy or rehabilitation program) to reduce risks like high blood pressure and high blood sugar. Suitable participants are those aged 18-39 with a diagnosis of colorectal cancer, whether currently receiving treatment or having completed treatment within the last two years. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance quality of life and care management for young people with colorectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for adolescents and young adults with colorectal cancer?

Research has shown that exercise programs for people with colorectal cancer are generally safe and manageable. Studies have found that exercising after a colorectal cancer diagnosis is linked to a low risk of serious side effects, meaning major problems are rare. Exercise can also enhance muscle strength and movement, helping patients feel stronger and more active.

One study found that people who exercised had a 37% lower risk of death compared to those who did not exercise. This suggests that exercise not only aids daily health but may also improve long-term survival.

Overall, these findings indicate that exercise is a safe and beneficial option for people dealing with colorectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise program for colorectal cancer patients because it offers a holistic approach that complements traditional treatments like surgery, chemotherapy, and radiation. Unlike these standard treatments, which primarily focus on removing or killing cancer cells, the exercise program aims to enhance overall physical function and quality of life. By incorporating regular physical activity, this approach may help reduce fatigue, improve strength, and boost mental well-being, potentially leading to better long-term outcomes for survivors. This trial seeks to uncover how exercise can be a powerful ally in the journey to recovery and sustained health.

What evidence suggests that this exercise program is effective for managing colorectal cancer in adolescents and young adults?

Research has shown that exercise programs can greatly benefit people with colorectal cancer. One study found that participants in a structured exercise program had an 80% chance of remaining cancer-free after five years, compared to 74% for those who only received health education. Another study demonstrated that exercise improved the likelihood of staying cancer-free by 28% and increased overall survival by 37%. Exercise also enhanced quality of life and fitness levels. This trial will incorporate an exercise program, indicating that exercise can play a crucial role in managing colorectal cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Kimberly Miller, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults who were diagnosed with colorectal cancer at any stage. Participants can be currently undergoing treatment if diagnosed within the last three months or be survivors 6-24 months post-diagnosis. They must understand and agree to sign a consent form.

Inclusion Criteria

I have been diagnosed with colorectal cancer.

Ability to understand and the willingness to sign a written informed consent

I have received some form of treatment before.

Exclusion Criteria

Patients who have a life expectancy of less than 6 months per their medical oncologist

Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases)

I was diagnosed over 3 months ago, or it's been more than 24 months since my initial diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Treatment

Participants on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months

6 months

3 visits (in-person)

Surveillance

Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline

6 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Program

Trial Overview The study measures physical function, collects biospecimens, reviews medical charts, tests physical performance, assesses quality of life, and administers questionnaires to understand the impact of colorectal cancer on this age group's health and daily living.

How Is the Trial Designed?

Group I: Physical function testing, questionnaire Experimental Treatment 5 Interventions

Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. asco.org asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ... At five years, the disease-free survival rate was 80% in the structured exercise program and 74% in the health education materials group.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560161/

Physical Activity Interventions for Colorectal Cancer Survivors We provided evidence that PA interventions were effective in improving disease-specific quality of life, PA level, and maximum amount of oxygen.

3. cancernetwork.com cancernetwork.com/view/new-colon-cancer-data-shows-importance-of-exercise-therapy-for-survival

New Colon Cancer Data Shows Importance of Exercise ... The exercise intervention group experienced a 28% improvement in disease-free survival (DFS) and a 37% improvement in overall survival (OS), ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635004/

Effect of home-based exercise prehabilitation on ... Home-based exercise prehabilitation does not reduce postoperative complications and length of hospital stay after CRC surgery.

5. ascopost.com ascopost.com/news/june-2025/structured-exercise-program-improves-survival-in-some-patients-with-colon-cancer/

Structured Exercise Program Improves Survival in Some ... Eight-year overall survival was 90% in the structured exercise program arm and 83% in health education materials arm (HR = 0.63; 95% CI = 0.43– ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40450658/

Structured Exercise after Adjuvant Chemotherapy for Colon ... The 5-year disease-free survival was 80.3% in the exercise group and 73.9% in the health-education group (difference, 6.4 percentage points; 95% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7513291/

Exercise and colorectal cancer: a systematic review ... The present findings suggest that exercise following colorectal cancer diagnosis is associated with a low risk of adverse event, is feasible, ...

8. healio.com healio.com/news/hematology-oncology/20250603/exercise-described-as-novel-firstinclass-colon-cancer-therapy

Exercise described as 'novel, first-in-class' colon cancer ... Results also showed a 37% lower risk for death among patients assigned to the exercise program (HR = 0.63), with an 8-year OS of 90% vs. 83%.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666262023000736

The effect of exercise in patients with colorectal cancer ... Studies have indicated that aerobic and resistance training can enhance surgical patients' muscle function and encourage mobility before and after colorectal ...

10. targetedonc.com targetedonc.com/view/structured-exercise-boosts-survival-in-colorectal-cancer

Structured Exercise Boosts Survival in Colorectal Cancer A 3-year structured exercise program significantly improved DFS and OS in stage II/III CRC, reducing recurrence by 28% and death risk by 37%.