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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise and physical activity monitoring can clarify health outcomes for people with advanced cancer. It examines the link between staying active and overall health and survival. Participants will use devices like fitness trackers and smartphones to monitor their activity and health symptoms. This trial suits those in Houston with certain types of cancer who can perform everyday activities and are interested in tracking their physical activity. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance cancer care and improve patient quality of life.

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 prior data suggests that this physical activity monitoring is safe for cancer patients?

Research has shown that exercise is generally safe for cancer survivors. Most studies find that exercise programs have little to no side effects. One study found that exercising at home was both feasible and safe for cancer patients, with the most common issues being minor, such as muscle soreness or fatigue.

Exercise is not only safe but also beneficial. It can reduce the risk of cancer recurrence or the development of a new type of cancer. While exercise is usually well-tolerated, individual experiences may vary. It is important to consult a healthcare provider before starting any new exercise routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Physical Activity Monitoring for Cancer Prognosis trial because it explores how technology can enhance cancer care by closely tracking physical activity and health metrics. Unlike traditional methods that might rely heavily on periodic doctor visits, this approach uses wearable devices and smartphones to gather real-time data on exercise, diet, and symptoms. This continuous monitoring could provide a more comprehensive picture of a patient’s health, potentially leading to more personalized and timely interventions. The use of devices like accelerometers, heart rate monitors, and CO monitors offers a new way to understand the impact of lifestyle factors on cancer prognosis and recovery. By integrating technology into patient care, researchers hope to improve outcomes and quality of life for cancer patients.

What evidence suggests that this trial's treatments could be effective for cancer prognosis?

Research has shown that physical activity greatly benefits cancer patients. This trial includes various arms to study the effects of exercise and physical activity monitoring on different cancer patient groups. Studies indicate that exercise can reduce treatment side effects such as tiredness and pain. It also enhances overall health and well-being for those with cancer. Exercise is associated with a lower risk of cancer recurrence and can even reduce death rates, particularly in breast cancer patients. Additionally, incorporating exercise into cancer care is becoming an important strategy to help patients feel better and manage their symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan K. Peterson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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)

You are currently smoking or have recently quit smoking when you come to MD Anderson Cancer Center.

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 are having trouble understanding where you are, what time it is, or who you are.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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]

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