Physical Activity Monitoring for Cancer Prognosis

Overseen By Susan Peterson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Major surgery, Cognitive difficulty, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

590 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.

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

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 Exercise Intervention, Physical Activity Intervention, Exercise Program, Aerobic and Resistance Training for cancer prognosis?

Research shows that physical activity can improve survival rates and quality of life for cancer survivors. Engaging in regular exercise is linked to lower mortality rates and may reduce the risk of cancer recurrence. ^{1 2 3 4 5}

Is physical activity safe for cancer patients?

Exercise therapy, including aerobic and resistance training, is generally safe for cancer patients. In a review of 48 studies involving 3,632 patients, only 44 adverse events were reported, indicating a low risk of harm. ^{3 6 7 8 9}

How does physical activity monitoring differ from other cancer treatments?

Physical activity monitoring is unique because it focuses on tracking and analyzing physical activity levels to improve cancer prognosis, rather than using medication or surgery. This approach leverages wearable devices to assess and encourage physical activity, which has been associated with improved survival rates in cancer patients. ^{3 10 11 12 13}

Research Team

Susan K. Peterson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with various advanced cancers, including head and neck, colorectal, and solid tumors. Participants must be able to consent, live in the Houston area, speak English fluently, have an ECOG status of 0-3 (meaning they can care for themselves more than half the day), and have telephone access.

Inclusion Criteria

Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)

Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)

I can take care of myself and am up more than half the day.

Exclusion Criteria

I have a condition that makes it hard for me to stand on a scale.

I have not had major surgery in the last 8 weeks.

You have a diagnosed or strongly suspected drug addiction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Usage

Participants use various devices to monitor physical activity, health-related symptoms, and other parameters for 5 consecutive days, followed by a 2-week break, and then another 5 days of device usage.

4 weeks

Device usage at home

Post-Surgical Wellness Program

Pancreatic surgery patients receive a wellness program consisting of physical activity, nutrition counseling, and daily monitoring for up to 7 months post-operation.

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on the correlation between physical activity data and overall survival.

4 weeks

Treatment Details

Interventions

• Exercise Intervention

Trial Overview The study aims to see if physical activity levels measured objectively are linked to health provider-assessed performance status and survival in advanced cancer patients. It involves health telemonitoring, questionnaires, exercise interventions, and quality-of-life assessments.

Participant Groups

Group I: TAPS (Technological Approach to Performance Status) Experimental Treatment 1 Intervention

Patients use two Physical Activity monitor devices, the wrist-worn device (Fitbit) continuously and the Actigraph during waking hours. Patients use the devices for 7 consecutive days.

Group II: PCS (pancreatic surgery patients) Experimental Treatment 4 Interventions

Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.

Group III: Arm IV (cancer survivors that are current/former smokers) Experimental Treatment 2 Interventions

(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a CO monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

Group IV: Arm III (head and neck cancer patients) Experimental Treatment 2 Interventions

(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days.

Group V: Arm II (head and neck cancer patients) Experimental Treatment 2 Interventions

(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

Group VI: Arm I (colorectal cancer patients) Experimental Treatment 2 Interventions

(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a GPS device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 1,589 cancer survivors, engaging in 360+ minutes of physical activity per week was linked to a significantly lower risk of cancer-specific mortality, with a hazard ratio of 0.30, indicating a strong protective effect.

Both long-term cancer survivors and cancer-free individuals who met the exercise guideline of 150 minutes per week showed reduced all-cause mortality, suggesting that regular physical activity is beneficial for overall health in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Survival among Long-term Cancer Survivor and Non-Cancer Cohorts. Gunnell, AS., Joyce, S., Tomlin, S., et al.[2022]

Physical activity (PA) has been shown to significantly improve quality of life for cancer survivors both during treatment and after, based on compelling clinical trial data.

Observational studies suggest that engaging in physical activity may lower the risk of cancer recurrence and potentially extend survival, making it a beneficial recommendation for most cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on quality of life and prognosis in cancer survivors. Speed-Andrews, AE., Courneya, KS.[2009]

In a study of 397 breast cancer survivors, engaging in more than 6.9 MET-h/week of physical activity was linked to a 34% reduction in all-cause mortality, indicating that physical activity can improve long-term survival after a breast cancer diagnosis.

The protective effects of physical activity were particularly significant in non-Hispanic White women and older women over 58 years, as well as those with localized cancer, suggesting that age and cancer stage may influence the benefits of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnic and biological differences in the association between physical activity and survival after breast cancer. Cao, Y., Baumgartner, KB., Visvanathan, K., et al.[2022]

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 and physical activity have therapeutic benefits for cancer survivors, improving physical function, reducing cancer-related symptoms, and enhancing overall quality of life.

Physical activity can influence cancer outcomes by altering biological pathways related to tumor initiation and may help prevent certain cancers, such as breast and colon cancer, while also addressing survivorship issues like fatigue and lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role and efficacy of exercise in persons with cancer. Eickmeyer, SM., Gamble, GL., Shahpar, S., et al.[2022]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

An 8-week aerobic exercise intervention for breast cancer survivors did not show significant improvements in key biomarkers of breast cancer risk overall, but participants who adhered to the program showed a notable decrease in waist circumference and an increase in reported physical activity.

The study involved 26 breast cancer survivors, and while the results were not statistically significant for the entire group, they suggest that high adherence to exercise may lead to beneficial changes in body composition and activity levels, indicating the need for further research with a larger sample size and longer duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aerobic exercise on metabolic and inflammatory markers in breast cancer survivors--a pilot study. Guinan, E., Hussey, J., Broderick, JM., et al.[2021]

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

Strength training (ST) significantly improves maximal strength in cancer survivors, with increases ranging from 20% to 50%, demonstrating its effectiveness in countering treatment-related declines in strength.

While ST also enhances physical function by 7% to 38%, improvements in body composition and psychosocial parameters were less consistent, indicating that strength gains are the most reliable benefit across various cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. Hanson, ED., Wagoner, CW., Anderson, T., et al.[2018]

Monitoring physical activity (PA) for just two days can provide reliable estimates of light PA in cancer survivors, but certain groups, such as those with a higher BMI or older age, may need an additional day for accuracy.

For moderate and moderate-to-vigorous PA, three days of monitoring is generally sufficient, while breast cancer survivors and those with higher BMI may require four days for reliable estimates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How many days of continuous physical activity monitoring reliably represent time in different intensities in cancer survivors. Western, B., Demmelmaier, I., Vistad, I., et al.[2023]

In a study of 293 patients with metastatic colorectal cancer (mCRC), higher levels of physical activity (PA) at diagnosis were linked to significantly longer overall survival, with moderate and high MET-hours showing hazard ratios of 0.491 and 0.485, respectively.

Adherence to the American College of Sports and Medicine (ACSM) physical activity guidelines also correlated with improved survival rates, suggesting that engaging in regular physical activity may be beneficial for mCRC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer. Smit, KC., Derksen, JWG., Beets, GLO., et al.[2022]

In a pilot study involving 24 cancer patients, physical activity monitors (PAMs) were found to be a feasible tool for assessing physical activity and performance status, with 96% of participants using the monitors for over half of the observation period.

PAM-measured physical activity levels correlated significantly with established quality-of-life measures, indicating that PAMs can effectively reflect patients' functional status during systemic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Wearable Physical Activity Monitors in Patients With Cancer. Gupta, A., Stewart, T., Bhulani, N., et al.[2019]

Engaging in vigorous-intensity physical activities before diagnosis is associated with significantly lower all-cause mortality in cancer patients, particularly those with colorectal cancer, suggesting that higher intensity exercise may improve survival rates.

Post-diagnosis, participating in more than two different types of physical activities is linked to lower all-cause mortality, indicating that variety in exercise may also play a role in enhancing survival outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pre- and post-diagnosis physical activity on the mortality of patients with cancer: Results from the Health Examinees-G study in Korea. Choi, J., Park, JY., Kim, JE., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity and Survival among Long-term Cancer Survivor and Non-Cancer Cohorts. [2022]

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

Effects of exercise on quality of life and prognosis in cancer survivors. [2009]

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

Ethnic and biological differences in the association between physical activity and survival after breast cancer. [2022]

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

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

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

The role and efficacy of exercise in persons with cancer. [2022]

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

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The effect of aerobic exercise on metabolic and inflammatory markers in breast cancer survivors--a pilot study. [2021]

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

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

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

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. [2018]

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

How many days of continuous physical activity monitoring reliably represent time in different intensities in cancer survivors. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer. [2022]

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

Feasibility of Wearable Physical Activity Monitors in Patients With Cancer. [2019]

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

Impact of pre- and post-diagnosis physical activity on the mortality of patients with cancer: Results from the Health Examinees-G study in Korea. [2023]