Exercise Program for Cancer Survivors

Overseen By Karen Basen-Engquist, BA,MPH,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Recent ALAC participation, others

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

Compensation: Varies

Number of Visits: Unknown

164 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research study is to learn more about a physical activity program adapted for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you can continue hormone therapy or long-term maintenance chemotherapy while participating.

What data supports the effectiveness of the treatment Active Living After Cancer for cancer survivors?

Research shows that exercise programs for cancer survivors can improve physical functioning and quality of life. Physical activity is linked to better health outcomes and prognosis for cancer survivors, and exercise interventions have been shown to enhance quality of life in this group. ^{1 2 3 4 5}

Is the exercise program for cancer survivors generally safe?

While exercise is generally beneficial for cancer survivors, the potential harms are not well-studied. Efforts are being made to improve how adverse outcomes (unwanted effects) are monitored and reported in exercise programs for cancer survivors. ^{4 6 7 8 9}

How is the Active Living After Cancer treatment different from other treatments for cancer survivors?

Active Living After Cancer is unique because it is a community-based physical activity program specifically adapted for minority and medically underserved breast cancer survivors, focusing on improving their physical functioning and quality of life. Unlike other treatments, it is designed to be accessible outside of clinical settings, making it more available to those who might not have access to traditional exercise programs. ^{6 10 11 12 13}

Research Team

Karen Basen-Engquist, BA,MPH,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer survivors over 18, living in specific areas of Houston, Texas (zip codes 77088 or 77091), who are not currently undergoing cancer treatment except hormone therapy or maintenance chemo. Caregivers can also join. Participants must be cleared for physical activity and cannot be pregnant or have attended the program extensively within the last year.

Inclusion Criteria

Screen negative for contraindicating health problems on the adapted Physical Activity Readiness Questionnaire (PAR-Q), or screened positive but have approval from a health care provider to participate

Lives in the Acres Homes neighborhood of Houston, Texas or has a home zip code of 77088 or 77091

Able to provide informed consent

Exclusion Criteria

I am currently pregnant.

I have been part of the ALAC program and attended over 2 sessions in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments before starting the intervention

1 week

Intervention

Participants receive the ALAC intervention

12 weeks

Waitlist Control

Participants in the control group receive the ALAC intervention after 3 months

12 weeks

Follow-up

Participants are monitored for program effects and maintenance at 6 months

6 months

Treatment Details

Interventions

• Active Living After Cancer

Trial Overview The study focuses on a physical activity program tailored for cancer survivors to understand its effects on their health and quality of life after completing cancer treatment.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

Receives the ALAC intervention following the baseline assessment

Group II: Waitlist Control Active Control 2 Interventions

Receives the ALAC intervention following the 3-month assessment

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Exercise programs significantly improve various health indicators in adult cancer patients after completing their main treatment, particularly in areas like muscle strength, fatigue, depression, and quality of life, based on a review of 34 studies.

Patients with breast cancer showed notable benefits from aerobic exercise, with improvements in physical functions such as a 29-meter increase in 6-minute walk distance, highlighting the efficacy of exercise in enhancing recovery and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programs for patients with cancer improve physical functioning and quality of life. McClellan, R.[2013]

Among cancer survivors, exercising in the afternoon (PM) led to significant improvements in fitness and lower-body muscular endurance, while morning (AM) or mixed exercise times did not show these benefits.

Mixed exercise timing was associated with less favorable outcomes, including increases in waist circumference, body weight, and BMI, suggesting that consistent AM or PM exercise may be better for weight management and overall health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between time-of-day of habitual exercise training and changes in relevant cancer health outcomes among cancer survivors. Coletta, AM., Playdon, MC., Baron, KG., et al.[2023]

Only about 34% of young-old (ages 65-74) and 35% of old-old (ages 75 and above) cancer survivors in the U.S. meet the recommended levels of aerobic physical activity, which is significantly lower than the 44% adherence rate in middle-aged cancer survivors (ages 45-64).

Approximately 10% of older cancer survivors meet both aerobic and muscle-strengthening activity guidelines, highlighting a need for increased support and encouragement for physical activity in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Physical Activity Levels of Older Cancer Survivors: Results from the 2014 National Health Interview Survey. Tarasenko, Y., Chen, C., Schoenberg, N.[2017]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

Exercise interventions significantly improve the quality of life (QOL) in cancer survivors, with more intense aerobic exercise showing particularly strong effects.

The benefits of exercise on QOL are especially pronounced in women and are more effective in studies with higher methodological quality and longer intervention durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for cancer survivors: a meta-analysis of quality of life outcomes. Ferrer, RA., Huedo-Medina, TB., Johnson, BT., et al.[2022]

The Active Living After Cancer program, designed for breast cancer survivors, effectively improved physical activity levels and quality of life among 127 participants, demonstrating significant enhancements in both mental and physical well-being after 12 weeks of community-based sessions.

Participants showed measurable improvements in physical functioning, with increased sit-to-stand repetitions and longer distances walked in a 6-minute test, indicating that the program successfully promoted better physical capabilities in minority and medically underserved survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Living After Cancer: Adaptation and evaluation of a community-based physical activity program for minority and medically underserved breast cancer survivors. Tami-Maury, IM., Liao, Y., Rangel, ML., et al.[2022]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

The ACTIVATE Trial demonstrated that using a Garmin Vivofit 2 activity monitor, along with behavioral coaching, significantly increased moderate to vigorous physical activity (MVPA) by an average of 69 minutes per week in breast cancer survivors over a 12-week period.

Participants in the intervention group also experienced a significant reduction in sedentary behavior, with decreases of 37 minutes per day in total sitting time and 42 minutes per day in prolonged sitting bouts, highlighting the effectiveness of wearable technology in promoting a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

Community-based exercise programs for cancer survivors have been shown to significantly improve quality of life, reduce fatigue, and enhance overall well-being.

Engaging in regular physical activity may also lower the risk of recurrence for certain cancers, such as breast and colon cancer, highlighting the importance of exercise in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. Musanti, R., Murley, B.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise programs for patients with cancer improve physical functioning and quality of life. [2013]

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

The association between time-of-day of habitual exercise training and changes in relevant cancer health outcomes among cancer survivors. [2023]

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

Self-Reported Physical Activity Levels of Older Cancer Survivors: Results from the 2014 National Health Interview Survey. [2017]

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

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Exercise interventions for cancer survivors: a meta-analysis of quality of life outcomes. [2022]

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

Active Living After Cancer: Adaptation and evaluation of a community-based physical activity program for minority and medically underserved breast cancer survivors. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

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

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. [2020]

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

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

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

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effects of a DVD-delivered randomized controlled physical activity intervention on functional health in cancer survivors. [2021]

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

Community-Based Exercise Programs for Cancer Survivors. [2018]