Physical Activity Program for Colorectal Cancer

(PACE Trial)

Overseen by Rachel Hirschey, Ph.D, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This research study tests the feasibility of the Physical Activity Centers Empowerment (PACE) physical activity intervention for African American individuals diagnosed with colorectal cancer. Feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. Seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.

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 data supports the effectiveness of the treatment Physical Activity Centers Empowerment, Physical Activity Intervention, PACE Program for colorectal cancer?

Research shows that physical activity can help improve both physical and psychological well-being in colorectal cancer patients. Home-based and computer-tailored physical activity programs have been found effective in supporting cancer survivors, suggesting that similar approaches like the PACE Program could be beneficial. ^{1 2 3 4 5}

Is the Physical Activity Program for Colorectal Cancer safe for humans?

Research on physical activity programs for colorectal cancer survivors shows they are generally safe, with high adherence rates and positive participant evaluations. No significant safety concerns were reported in the studies reviewed. ^{3 4 5 6 7}

How is the Physical Activity Centers Empowerment (PACE) treatment different from other treatments for colorectal cancer?

The PACE treatment is unique because it focuses on increasing physical activity through a structured program, which can improve physical fitness and potentially reduce the risk of cancer recurrence. Unlike traditional medical treatments, this program empowers patients to engage in home-based exercise, making it accessible and tailored to individual preferences. ^{4 5 6 8 9}

Research Team

Rachel Hirschey, Ph.D, RN

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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.

I am 18 years old or older.

Self-identifying as African American or Black

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)

Trial Timeline

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

Treatment Details

Interventions

• Physical Activity Centers Empowerment (Behavioural Intervention)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Dr. Eliseo J. Pérez-Stable

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Executive Officer since 2015

MD from University of Miami

Dr. Rada Dagher

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Medical Officer since 2024

MD from University of California, San Francisco

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Home-based physical activity intervention for colorectal cancer survivors. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. Ireland pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2018]

6. United States 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. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. [2022]

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

Identification and evaluation of the salient physical activity beliefs of colorectal cancer survivors. [2022]

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

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