Physical Activity Program for Breast and Colon Cancer Survivors

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Metastatic disease, Recurrence, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of exercise coaching and self-monitoring, assessed through the Physical Activity Index Assessment, can help breast and colon cancer survivors become more active and reduce sedentary time. Participants will begin the exercise program either immediately or after a six-month delay. It is ideal for breast or colon cancer survivors who completed their main treatments at least three months ago and have access to video calls. As an unphased trial, it provides a unique opportunity for survivors to enhance their recovery journey through increased physical activity.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity rather than changing medication use.

What prior data suggests that this physical activity program is safe for cancer survivors?

Research has shown that exercise programs are generally safe for breast and colon cancer survivors. These programs can reduce the negative side effects of cancer treatment, improving quality of life and functional ability. Many participants report feeling better and more active after completing their cancer treatments.

The program under study includes an assessment of physical activity levels, exercise coaching, and self-monitoring. This plan aims to help patients remain active and avoid inactivity. Although detailed safety data from this specific study is not yet available, exercise in cancer recovery is widely considered safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of physical activity on breast and colon cancer survivors, which is a novel approach compared to traditional treatments like chemotherapy, radiation, and hormone therapy. Unlike typical treatments that focus directly on eradicating cancer cells, this trial is about enhancing the overall well-being and recovery of survivors through guided exercise. The unique aspect of this trial is its focus on the timing of exercise, comparing immediate versus delayed exercise intervention, which could reveal insights into optimizing recovery and improving long-term health outcomes for cancer survivors.

What evidence suggests that this physical activity program is effective for increasing activity in breast and colon cancer survivors?

Research shows that cancer survivors who stay active tend to feel much healthier. In this trial, participants in the Exercise Group will follow a structured exercise program, including guidance and self-tracking, to help them remain active after treatment. Those who exercise enough to reach at least 22.5 MET hours per week are more than five times as likely to feel healthy compared to those who are less active. Participants in the Delayed Exercise Group will start their exercise program after a 6-month period. These programs are linked to better overall health and improved physical abilities. Overall, staying active can offer significant health benefits for breast and colon cancer survivors. ^{1 2 5 6 7}

Who Is on the Research Team?

Shirley Bluethmann

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast and colon cancer survivors who are interested in increasing their physical activity. Participants should be willing to use educational materials, wear an activity tracker, complete health surveys, and possibly receive exercise coaching calls.

Inclusion Criteria

Access to internet or cellular plan for video calls

Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly

I was diagnosed with breast or colon cancer at stage 0-III in the last three years.

Exclusion Criteria

Participants has prior conditions that contraindicate exercise as determined by treating physician

Participants has gross cognitive impairment as determined by treating physician

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Pre-exercise Consultation

Participants receive a pre-exercise screening call and consultation

1 week

1 visit (virtual)

Exercise Intervention

Participants engage in exercise sessions supported by coaching and self-monitoring tools

6 months

6 visits (in-person)

Follow-up

Participants are monitored for adherence and retention through questionnaires

11 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Index Assessment

Trial Overview The study tests if a Physical Activity Index screener combined with exercise coaching and self-monitoring can help survivors of breast or colon cancer become more active and spend less time sitting.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 7 Interventions

Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.

Group II: Delayed Exercise Group Active Control 6 Interventions

Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The BEAT Cancer intervention significantly improved key social cognitive factors such as self-efficacy, goal setting, and perceived barriers to physical activity among 222 post-treatment breast cancer survivors over a 3-month period.

Despite these improvements in social cognitive constructs, the intervention did not lead to significant indirect effects on increasing physical activity levels measured 6 months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Rogers, LQ., Courneya, KS., Anton, PM., et al.[2021]

Cancer survivors who engage in at least 22.5 MET hours/week of physical activity are over 5 times more likely to report excellent health compared to those who do not exercise, highlighting the significant health benefits of physical activity for this group.

Higher scores on a multi-component physical activity index (PAI) are associated with better self-rated health and lower likelihood of multimorbidity and functional limitations in cancer survivors, suggesting that tailored exercise programs could enhance health outcomes for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rethinking physical activity assessment in cancer survivors: a multi-component approach using NHANES data. Bluethmann, SM., Keadle, SK., King, TS., et al.[2022]

The Fit2Thrive intervention, which included a Fitbit and smartphone app, significantly improved patient-reported outcomes (PROs) such as anxiety, depression, fatigue, and physical functioning among 269 breast cancer survivors over a 12-week period, with benefits maintained at 24 weeks.

However, the specific components of the intervention (like support calls or text messages) did not show significantly different effects on PROs, suggesting that the core intervention itself is effective without needing to enhance individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. Solk, P., Song, J., Welch, WA., et al.[2023]

In a study of 377 breast cancer survivors, those who received breast cancer-specific print materials and pedometers significantly increased their physical activity (PA) by 89 minutes per week compared to only 30 minutes in the standard recommendation group, highlighting the effectiveness of tailored interventions.

The combined approach of using both print materials and pedometers not only increased PA but also improved quality of life (QoL) and reduced fatigue, suggesting that personalized strategies can enhance overall well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. Vallance, JK., Courneya, KS., Plotnikoff, RC., et al.[2022]

Breast cancer survivors engage in significantly more moderate- to vigorous-intensity physical activity (MVPA) compared to adults without cancer, averaging 29 minutes per day versus 22 minutes per day, indicating a potential positive adaptation post-treatment.

Colon cancer survivors exhibit lower levels of light-intensity physical activity and increased sedentary time compared to adults without cancer, suggesting a need for targeted interventions to improve their overall activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Sedentary Behavior in Breast and Colon Cancer Survivors Relative to Adults Without Cancer. Shi, JW., MacInnis, RJ., Boyle, T., et al.[2018]

The FitMáx©-questionnaire demonstrated moderate criterion validity for estimating aerobic capacity in cancer survivors, with an intraclass correlation coefficient (ICC) of 0.69, making it a reliable tool compared to the cardiopulmonary exercise test (CPET).

While the FitMáx©-questionnaire showed limited responsiveness for measuring absolute changes in aerobic capacity, it effectively detected improvements, achieving an area under the curve (AUC) of 0.77 in ROC analysis, outperforming the Duke Activity Status Index (DASI) and Veterans Specific Activity Questionnaire (VSAQ).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring aerobic capacity in cancer survivors using self-reported questionnaires: criterion validity and responsiveness. Weemaes, ATR., Meijer, R., Beelen, M., et al.[2023]

Adding behavioral counseling to a 4-week supervised physical activity program for kidney cancer survivors showed feasibility and a potential increase in physical activity levels, although the increase was not statistically significant.

Participants receiving behavioral counseling improved their 6-minute walk distance significantly more than those receiving standard exercise counseling, suggesting that behavioral strategies may enhance fitness outcomes in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Trinh, L., Plotnikoff, RC., Rhodes, RE., et al.[2014]

In a study of 1003 adult cancer survivors, those who believed that physical activity (PA) improves their quality of life and overall survival were significantly more likely to meet moderate to vigorous PA guidelines after treatment, highlighting the importance of patient perceptions in promoting activity levels.

Only 32% of patients met PA guidelines before diagnosis, but 50% of those who did maintained this after treatment, suggesting that factors like better health status and receiving curative therapy can help sustain PA levels post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns, perceptions, and perceived barriers to physical activity in adult cancer survivors. Eng, L., Pringle, D., Su, J., et al.[2018]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11412813/

Impact of the Promoting Physical Activity in Regional and ... In general, PA interventions in cancer survivors have resulted in higher global HRQoL and improved physical functioning (16, 36) with weaker ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04262180

Physical Activity Promotion for Breast and Endometrial ... The purpose of this study is test an adaptive physical activity intervention approach that reserves the most resources and support for women who do not fare ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392651/

Study design and methods for the physical activity index ... Study design and methods for the physical activity index (PAI) feasibility pilot trial for breast and colon cancer survivors in North Carolina.

4. withpower.com withpower.com/trial/phase-colonic-neoplasms-6-2024-94a54

Physical Activity Program for Breast and Colon Cancer ... Cancer survivors who engage in at least 22.5 MET hours/week of physical activity are over 5 times more likely to report excellent health compared to those who ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2024-04854

Evaluation of a Physical Activity Index, Exercise Coaching ... Utilizing the PAI screener along with exercise coaching and self-monitoring tools may help patients stay more active after completion of cancer treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782413/

Impact of physical exercise programs in breast cancer ... Physical exercise reduces the impact of treatment-related adverse events to promote a better quality of life and functional outcomes.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06340503/evaluating-a-physical-activity-index-for-assessment-and-counseling-for-breast-and-colon-cancer-survivors

Evaluating a Physical Activity Index for Assessment and ... ... Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.