Physical Activity Program for Breast and Colon Cancer Survivors

Overseen by Shirley Bluethmann

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Metastatic disease, Recurrence, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

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 data supports the effectiveness of the treatment Physical Activity Program for Breast and Colon Cancer Survivors?

Research shows that physical activity during and after cancer treatment can lead to better health outcomes for cancer survivors. Additionally, using tools like self-monitoring and exercise coaching can help increase physical activity levels, which is beneficial for overall health. ^{1 2 3 4 5}

Is physical activity safe for cancer survivors?

Research shows that physical activity is generally safe for cancer survivors and can improve both physical and psychological health. ^{1 2 3 6 7}

How is the Physical Activity Program for Breast and Colon Cancer Survivors treatment different from other treatments?

This treatment is unique because it combines a multi-component approach to assess and enhance physical activity through self-monitoring, exercise coaching, and personalized feedback, which is specifically tailored for cancer survivors to improve their physical and psychological health. ^{1 3 6 8 9}

Research Team

Shirley Bluethmann

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

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

Able to read and speak English

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• Physical Activity Index Assessment (Behavioural Intervention)

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.

Participant Groups

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+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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 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]

References

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

Rethinking physical activity assessment in cancer survivors: a multi-component approach using NHANES data. [2022]

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

Patterns, perceptions, and perceived barriers to physical activity in adult cancer survivors. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). [2022]

4. United States 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. [2014]

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

Monitoring aerobic capacity in cancer survivors using self-reported questionnaires: criterion validity and responsiveness. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Physical Activity and Sedentary Behavior in Breast and Colon Cancer Survivors Relative to Adults Without Cancer. [2018]

8. United States 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. [2022]

9. England 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. [2021]