Physical Activity and Education for Colorectal Cancer

(CHALLENGE Trial)

Recruiting at 48 trial locations

Overseen By Chris O'Callaghan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Must not be taking: Anticancer treatments

Disqualifiers: Rectal cancer, Other malignancies, others

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

Compensation: Varies

Number of Visits: 48

889 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any concurrent anticancer treatment, including chemotherapy, biological, or targeted agents. You also cannot take medications that the investigator thinks might prevent you from participating in the physical activity program.

Is physical activity safe for people with colorectal cancer?

Physical activity is generally safe for people with colorectal cancer and can improve quality of life, reduce the risk of cancer recurrence, and enhance overall health outcomes. ^{1 2 3 4 5}

How does the Physical Activity Program and Health Education Materials treatment differ from other treatments for colorectal cancer?

This treatment is unique because it focuses on incorporating physical activity and health education to improve quality of life and potentially reduce mortality in colorectal cancer patients, rather than relying solely on traditional medical treatments like surgery or chemotherapy. Physical activity is shown to have benefits such as slowing functional decline and improving overall survival, which are not typically addressed by standard cancer treatments. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Health Education Materials, Physical Activity Program for colorectal cancer?

Research shows that physical activity can improve quality of life, slow down functional decline, and reduce mortality in colorectal cancer patients. Additionally, exercise programs after surgery have been associated with improved physical recovery and increased flexibility. ^{1 4 6 9 10}

Who Is on the Research Team?

Janette Vardy, PhD, FRACP

Principal Investigator

Sydney Cancer Centre at Concord Repatriation General Hospital

Kerry Courneya, PhD

Principal Investigator

University of Alberta

Christopher Booth, MD

Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Are You a Good Fit for This Trial?

This trial is for patients who've completed certain chemotherapy for high-risk stage II or III colon cancer within the last 60-180 days. They should be able to communicate, complete questionnaires and exercise tests, not meet current physical activity guidelines, and have no evidence of recurring cancer. Pregnant individuals or those planning pregnancy in the next 3 years are excluded.

Inclusion Criteria

Your platelet count is at least 100,000 per cubic millimeter.

My cancer is at stage T4.

My cancer is at stage III, confirmed by a positive lymph node or tumor deposit.

Exclusion Criteria

I am not currently receiving any other chemotherapy or radiation treatments.

I am not currently on any cancer treatments like chemotherapy.

I have had radiotherapy for my initial cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Intervention

Participants undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 MET hours/week.

6 months

12 visits (in-person)

Reduced Intervention

Participants undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.

6 months

12 visits (in-person or virtual)

Minimal Intervention

Participants undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.

24 months

24 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-10 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Materials
• Physical Activity Program

Trial Overview The study compares two approaches: one group receives health education materials plus a physical activity program designed to increase free time physical activity; another group gets only the health education materials. The goal is to see which method better prevents cancer recurrence and improves fitness and well-being.

How Is the Trial Designed?

Group I: Physical Activity Program + General Health Education Materials Active Control 9 Interventions

Intervention Arm

Group II: General Health Education Materials Active Control 7 Interventions

Control Arm

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Queen's University, Belfast

Collaborator

Trials

179

Recruited

142,000+

Survivorship Research Group

Collaborator

Trials

1

Recruited

890+

Published Research Related to This Trial

Health professionals often missed opportunities to promote physical activity (PA) during the chemotherapy treatment of colorectal cancer patients, despite its importance for managing side effects and maintaining function.

Post-treatment, there was a noticeable increase in PA promotion by health professionals, indicating a need for better integration of PA support throughout the entire cancer treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for physical activity management at key points throughout the chemotherapy pathway for colorectal survivors: an observational interview study. Veal, I., Peat, N., Jones, GD., et al.[2022]

A six-month mixed exercise program significantly improved flexibility, lower limb strength, and aerobic capacity in patients recovering from colorectal cancer surgery, compared to a control group that did not exercise.

Patients in the exercise group also experienced a notable reduction in body fat and an increase in cell mass, highlighting the potential of exercise to enhance physical recovery after surgery for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial. Mascherini, G., Ringressi, MN., Castizo-Olier, J., et al.[2020]

Only 25.60% of colorectal cancer survivors in the study met the physical activity guidelines, indicating a need for improved activity levels among these patients.

Factors such as fatigue, body image, depression, and self-efficacy were found to be closely linked to physical activity levels, suggesting that addressing these issues could help increase physical activity in colorectal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. Kang, DQ., Li, Y., Chen, ZQ., et al.[2021]

Colorectal cancer mortality has decreased over the past 20 years, largely due to better screening and treatment options.

Incorporating physical activity into the management plan for colorectal cancer survivors is crucial, as it enhances quality of life, slows functional decline, and reduces overall mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical activity on survival in patients with colorectal cancer. DeTroye, A., Christner, M., Eganhouse, D., et al.[2018]

A ten-step development process was used to create a safe and effective inpatient exercise program for colorectal cancer patients recovering from surgery, which included systematic reviews and expert discussions.

The exercise program significantly reduced the length of hospital stays and the time to flatus, indicating improved recovery outcomes for patients after colectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. An, KY., In Yang, H., Kang, DW., et al.[2020]

In a study of 47 colorectal cancer patients, factors such as knee extensor muscle strength, fatigue severity, and quality of life significantly influenced physical activity levels, explaining 43% of the variance in activity.

Moderate correlations were found between physical activity and muscle strength, balance, and fatigue, indicating that improving these factors could enhance physical activity and overall well-being in CRC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing physical activity in patients with colorectal cancer. Kucukvardar, D., Karadibak, D., Ozsoy, I., et al.[2021]

Physical activity is beneficial for colorectal cancer survivors, as it can reduce the risk of colon cancer recurrence and improve overall quality of life and cardiovascular health, based on a review of existing data.

While the evidence for rectal cancer survivors is less strong, physical activity still shows positive effects on quality of life and health outcomes, potentially through mechanisms involving inflammation and insulin-like growth factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. Denlinger, CS., Engstrom, PF.[2021]

Physical inactivity is linked to 13-14% of colon cancer cases, suggesting that being active may be more important than family history in reducing risk.

While there is some evidence that physical activity can improve outcomes after a colorectal cancer diagnosis, the specific effects of exercise interventions on cancer risk and prognosis remain unclear, and no optimal exercise regimen has been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. Harriss, DJ., Cable, NT., George, K., et al.[2021]

A review of 19 cohort studies found that physically active males have a significantly reduced risk of colon cancer, with risk ratios of 0.79 for occupational activities and 0.78 for recreational activities.

For women, only recreational physical activities were associated with a protective effect against colon cancer (RR = 0.71), while no significant protection was observed for rectal cancer in either sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. Samad, AK., Taylor, RS., Marshall, T., et al.[2006]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Missed opportunities for physical activity management at key points throughout the chemotherapy pathway for colorectal survivors: an observational interview study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of physical activity on survival in patients with colorectal cancer. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Factors influencing physical activity in patients with colorectal cancer. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Exercise and diet in colorectal cancer prevention and therapy]. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. [2006]