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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special exercise program tailored for cancer survivors. It aims to understand how physical activity can benefit those who have completed cancer treatment, except for hormone therapy or maintenance chemotherapy. Participants will either begin the exercise program, called Active Living After Cancer, immediately or after a few months. Individuals who had invasive cancer or are caregivers, live in specific Houston areas, and are not currently undergoing cancer treatment may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life 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 prior data suggests that this exercise program is safe for cancer survivors?

Research has shown that exercise programs like Active Living After Cancer are generally safe for cancer survivors. One study found that being active is safe for most people undergoing cancer treatment. However, participants should always consult their healthcare team before starting any new exercise routine. Another study found that survivors who joined community exercise programs designed for them experienced significant benefits without major safety issues.

After completing such a program, the number of survivors meeting recommended activity levels increased from 29% to 60%. This indicates that the program is not only effective but also well-tolerated by participants. Overall, evidence supports that joining these exercise programs is safe and beneficial for cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Active Living After Cancer (ALAC) program because it offers a unique approach to supporting cancer survivors. Unlike traditional treatments like medication or surgery, this program emphasizes physical activity and lifestyle changes to improve survivors' quality of life. By focusing on exercise, ALAC aims to address long-term health and well-being, potentially reducing recurrence risks and enhancing overall recovery. This holistic approach is a promising complement to standard cancer care, empowering survivors to actively participate in their health journey.

What evidence suggests that this exercise program is effective for cancer survivors?

Research has shown that the Active Living After Cancer (ALAC) program helps cancer survivors become more active. One study found that participants increased their physical activity from 29% to 60% after completing the program. Another study reported that survivors who often lack medical resources experienced better physical function and quality of life. Additionally, 95% of participants expressed satisfaction with the program, and all would recommend it to others. In this trial, participants in the intervention arm will receive the ALAC program following the baseline assessment, while those in the waitlist control arm will receive it after the 3-month assessment. These findings support the program's success in helping cancer survivors stay active and improve their overall well-being. ^{4 6 7 8 9}

Who Is on the Research Team?

Karen Basen-Engquist, BA,MPH,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38688563/

Expanding active living after cancer to underserved ... - PubMed

Conclusions: The ALAC program demonstrated increased physical activity, physical function, and QOL in medically underserved cancer survivors ...

2.

cancer.gov

cancer.gov/news-events/cancer-currents-blog/2024/cancer-survivors-minority-underserved-improving-activity

Program Improves Physical Activity in Cancer Survivors - NCI

After completing the program, the percentage of survivors getting recommended levels of physical activity jumped dramatically, from 29% to 60%.

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e24034

Active Living After Cancer (ALAC) program: An avenue to ...

Overall, 95.3% of participants were satisfied with the ALAC program and 100% of participants would recommend the ALAC program to other cancer ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1040842824003457

Grading the evidence for physical activity and any outcome ...

In a recent study from a US nationally representative cohort of cancer survivors, more than half reported no physical activity and two-thirds reported sitting ...

5.

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.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8738132/

Active Living After Cancer: Adaptation and evaluation of a ...

This report presents an evaluation of Active Living After Cancer, an evidence‐based physical activity program for breast cancer survivors, adapted for ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4821160/

Community-based exercise program effectiveness and ...

Survivors may expect significant benefit from participating in a community-based exercise program tailored to meet their individual needs as a survivor.

8.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21721

Nutrition and Physical Activity Guideline for Cancer Survivors

Being physically active is safe for most people getting cancer treatment. However, it's still important for people to check with their care team ...

9.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK_349635

Exercise Across the Cancer Care Continuum: Why It ...

It is estimated that between 17% and 58% of cancer survivors adhere to physical activity guidelines. In addition to these prevention and ...