Physical Activity Program for Colorectal Cancer

(PACE Trial)

Overseen By Cason E Whitcomb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Non-AA, No CRC, Under 18, 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: 3

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a physical activity program for African American individuals diagnosed with colorectal cancer. Participants will either join an active group, receiving tools like a Fitbit, daily step goals, and monthly Zoom meet-ups, or a control group that will access resources after the study. The researchers aim to determine if the program is user-friendly, effective, and sustainable over time. Ideal candidates identify as African American, have colorectal cancer, are about to begin chemotherapy, and possess a smartphone. As an unphased trial, this study provides participants an opportunity to contribute to research that could enhance cancer care within their community.

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 the PACE Program is safe for African American individuals with colorectal cancer?

Research has shown that exercise benefits people with colorectal cancer. It can reduce side effects, help patients complete treatments, and even improve survival rates. The Physical Activity Centers Empowerment program encourages participants to be more active. This program promotes exercise, which is generally safe for most people.

No specific safety concerns have emerged for this type of program. Participants usually find exercise programs like this manageable. However, participants should consult their healthcare provider about any concerns to ensure the program suits their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to supporting colorectal cancer patients through a structured physical activity program. Unlike conventional treatments that primarily focus on surgery, chemotherapy, and radiation, this method aims to empower patients by integrating physical activity into their recovery process. Key features include the use of a Fitbit to set personalized daily step goals, motivational text messages, and monthly Zoom meetings for community support, which could enhance quality of life and potentially improve outcomes. This trial seeks to discover whether such a supportive and interactive program can make a meaningful difference in recovery and overall well-being for colorectal cancer patients.

What evidence suggests that the PACE Program is effective for colorectal cancer?

This trial will evaluate the impact of the Physical Activity Centers Empowerment (PACE) Program, a structured exercise program, on individuals with colorectal cancer. Studies have shown that exercise benefits people with colorectal cancer by reducing side effects, improving treatment outcomes, and extending survival. For instance, one study found that participants in a structured exercise program had an 80% chance of being disease-free after five years, compared to 74% for those who only received health education materials. Another study demonstrated that exercise programs can enhance quality of life and increase fitness levels. Overall, staying active appears to help individuals with colorectal cancer feel better and live longer. Participants in the intervention arm of this trial will receive access to a video library, a Fitbit, daily adaptive step goals, and monthly Zoom meetings to discuss physical activity. ^{1 2 6 7 8}

Who Is on the Research Team?

Rachel Hirschey, Ph.D, RN

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for African American individuals who have been diagnosed with colorectal cancer. It aims to test a new program designed to help them be more active.

Inclusion Criteria

My diagnosis is a specific type of colon/rectum cancer.

Self-identifying as African American or Black

Oncologist approval to participate

Exclusion Criteria

Does not own a smartphone with an active data plan or tablet (for Fitbit syncing)

Contraindications to unsupervised PA, as determined by the PA readiness questionnaire

No internet access (for viewing PACE video)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a physical activity intervention including access to a video library, a Fitbit, adaptive step goals, and monthly Zoom meetings

3 months

Monthly Zoom meetings

Follow-up

Participants are monitored for maintenance of physical activity and other outcomes post-intervention

6 months

Assessments at 3 and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Centers Empowerment

Trial Overview The study is testing the PACE program, which includes website access, monthly Zoom meetings, narrative videos, a Fitbit tracker, daily texts, and printed materials. Participants will be randomly placed into two groups to compare outcomes.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 5 Interventions

Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.

Group II: Control Arm Experimental Treatment 2 Interventions

Subjects will receive access to the video library after the study period (after the 9-month assessment).

Physical Activity Centers Empowerment is already approved in United States for the following indications:

Approved in United States as Physical Activity Centers Empowerment for:

• Improving physical activity in African American individuals diagnosed with colorectal cancer

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A home-based physical activity intervention for colorectal cancer survivors significantly increased physical activity levels and aerobic fitness over 12 months, particularly at the 3-month mark, compared to a control group.

The intervention also improved motivational readiness for physical activity at 3 months, although no significant differences were observed in fatigue, physical functioning, or quality of life between the groups over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based physical activity intervention for colorectal cancer survivors. Pinto, BM., Papandonatos, GD., Goldstein, MG., et al.[2022]

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]

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 study involving 600 colorectal cancer survivors found that beliefs about improved fitness and support from family significantly influence their physical activity behavior, highlighting the importance of social and personal motivations.

The research suggests that effective interventions to promote physical activity in CRC survivors should address various beliefs, as these are strongly linked to their motivation and actual physical activity levels, potentially improving their quality of life and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and evaluation of the salient physical activity beliefs of colorectal cancer survivors. Speed-Andrews, AE., McGowan, EL., Rhodes, RE., et al.[2022]

The OncoActive intervention, which included a pedometer and computer-tailored physical activity advice, significantly increased self-reported physical activity among prostate and colorectal cancer survivors, with improvements noted at both 3 and 6 months after the intervention.

Participants in the OncoActive group also experienced significant improvements in physical functioning, fatigue, and depression, particularly among colorectal cancer survivors, indicating that tailored interventions can enhance recovery and quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: a randomized controlled trial. Golsteijn, RHJ., Bolman, C., Volders, E., et al.[2018]

A 6-week home-based exercise program significantly increased physical activity levels by an average of 269.4 minutes per week in stage II to III colorectal cancer survivors, demonstrating its feasibility and effectiveness.

Participants in the exercise group also showed significant improvements in physical fitness, as evidenced by better performance in step and push-up tests compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the 6-week home-based exercise program on physical activity level and physical fitness in colorectal cancer survivors: A randomized controlled pilot study. Lee, MK., Kim, NK., Jeon, JY.[2022]

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]

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]

A 12-week supervised exercise program for colorectal cancer survivors was found to be feasible, with a high adherence rate of 91% and a completion rate of over 93% for assessments, indicating strong participant engagement.

The program significantly improved health-related physical fitness, including increases in peak oxygen uptake and body strength, as well as reductions in waist circumference and body fat, which may enhance quality of life and survival for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. Sellar, CM., Bell, GJ., Haennel, RG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579295/

Community-Engaged Approach to Increase Physical Activity ... Physical activity (PA) has been associated with decreased side effects, improved CRC treatment completion rates and responses, and survival.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06411756

Study Details | NCT06411756 | Physical Activity Centers ... The purpose of this research is to improve the quality of life for underserved cancer survivors by increasing physical activity. A physical activity ...

3. 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.

4. researchgate.net researchgate.net/publication/383831186_Community_engaged_approach_to_increase_physical_activity_among_Black_individuals_with_colorectal_cancer_Design_of_the_Physical_Activity_Centers_Empowerment_PACE_feasibility_randomized_controlled_trial

Design of the Physical Activity Centers Empowerment ... Physical activity (PA) participation has been associated with decreased side effects, improved CRC treatment completion rates and responses, and ...

5. 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.

6. researchgate.net researchgate.net/publication/392353107_Community_engaged_approach_to_increase_physical_activity_among_Black_individuals_with_colorectal_cancer_Design_of_the_Physical_Activity_Centers_Empowerment_PACE_feasibility_randomized_controlled_trial

Community engaged approach to increase physical activity ... Background Black individuals are more likely to die from colorectal cancer (CRC) and experience more treatment-related side effects compared ...

7. app.trialscreen.org app.trialscreen.org/trials/physical-activity-centers-empowerment-trial-nct06411756

Physical Activity Centers Empowerment The goal is to test the feasibility of a physical activity intervention tailored for African American individuals diagnosed with colorectal cancer. Check ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00230646

Promoting Physical Activity After Colorectal Cancer Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 ( ...