889 Participants Needed

Physical Activity and Education for Colorectal Cancer

(CHALLENGE Trial)

Recruiting at 48 trial locations
CO
Overseen ByChris O'Callaghan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Canadian Cancer Trials Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.14678

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.346910

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.

Research Team

JV

Janette Vardy, PhD, FRACP

Principal Investigator

Sydney Cancer Centre at Concord Repatriation General Hospital

KC

Kerry Courneya, PhD

Principal Investigator

University of Alberta

CB

Christopher Booth, MD

Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Eligibility Criteria

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.
See 31 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: Physical Activity Program + General Health Education MaterialsActive Control9 Interventions
Intervention Arm
Group II: General Health Education MaterialsActive Control7 Interventions
Control Arm

Find a Clinic Near You

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+

Findings from Research

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

References

Missed opportunities for physical activity management at key points throughout the chemotherapy pathway for colorectal survivors: an observational interview study. [2022]
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]
Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. [2021]
The effects of physical activity on survival in patients with colorectal cancer. [2018]
Development process of an evidence-based exercise program for post-operative colorectal cancer patients. [2020]
Factors influencing physical activity in patients with colorectal cancer. [2021]
[Exercise and diet in colorectal cancer prevention and therapy]. [2023]
Colorectal cancer survivorship: movement matters. [2021]
Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. [2021]
A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. [2006]
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