Activity Monitoring for Cancer Performance Status

Recruiting at 1 trial location

Overseen By Sandy Tran, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Movement disorder drugs

Disqualifiers: Missing limbs, Symptomatic brain metastases, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. Movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. The use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it is important to discuss this with the trial coordinators or your doctor to ensure there are no conflicts with the study requirements.

Are wearable activity monitors safe for use in humans, including cancer patients?

Wearable activity monitors, like fitness trackers, are generally considered safe for use in humans, including cancer patients. They are widely used to track physical activity and have been found to be acceptable and useful in motivating behavior change without significant safety concerns reported. ^{1 2 3 4 5}

How does the treatment using activity monitoring differ from other cancer treatments?

This treatment is unique because it uses wearable activity monitors to track physical activity in real-time, providing objective data that can help assess a cancer patient's performance status. Unlike traditional methods that rely on self-reported questionnaires, these devices offer more accurate and unbiased information, which can be used to guide clinical decisions and motivate patients to increase their physical activity. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Movement and Fitness Trackers, Wearable Activity Monitors, Fitness Trackers, Physical Activity Monitors in cancer patients?

Research shows that wearable activity monitors can provide accurate, real-time data on physical activity, which helps assess performance status in cancer patients. Increased daily steps were linked to fewer adverse events, hospitalizations, and a lower risk of death, suggesting these devices can predict clinical outcomes and improve patient care. ^{1 2 7 8 9}

Who Is on the Research Team?

Jorge J. Nieva

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for cancer patients who can walk unaided, are being screened for early phase clinical trials at USC/Norris, own a smartphone, and agree to wear activity trackers. They must understand English, Spanish or traditional Chinese. People with missing lower limbs, symptomatic brain metastases or severe movement disorders requiring medication cannot join.

Inclusion Criteria

Owns a smartphone

Ability to understand and the willingness to sign a written informed consent

I can walk on my own without needing help from devices.

Exclusion Criteria

I have brain metastases but no symptoms, or I am on steroids for them.

I am missing one or both of my lower limbs.

I have a severe movement disorder like Parkinson's that needs medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Activity Assessment

Participants wear outpatient activity trackers for 7 days to establish baseline activity classification

1 week

1 visit (in-person)

Early and Developmental Therapeutics (EDT) Monitoring

Participants are monitored for serious adverse events and activity level changes during the first 60 days of the EDT trial

8 weeks

1 visit (in-person), continuous monitoring with Fitbit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Movement and Fitness Trackers

Trial Overview The study is testing if using fitness trackers to monitor physical activity and other metrics like heart rate can more accurately determine the performance status of cancer patients in clinical trials and predict risks for adverse events and hospitalization.

How Is the Trial Designed?

Group I: Prevention (Fitbit, PRO diary) Experimental Treatment 2 Interventions

Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based PRO diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Wearable activity monitors are increasingly utilized in oncology trials to provide objective data on physical activity, with 41 trials identified, primarily involving cancer survivors and breast cancer patients.

These monitors can help assess daily activity levels, revealing that cancer survivors take between 4660 and 11,000 steps per day, while those undergoing treatment take 2885 to 8300 steps, indicating a need for further standardization in data collection and analysis to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable activity monitors in oncology trials: Current use of an emerging technology. Gresham, G., Schrack, J., Gresham, LM., et al.[2019]

Commercially available physical activity monitors offer oncologists a reliable way to objectively measure physical activity in cancer patients, overcoming the biases of self-reporting and short testing durations.

While these devices have been validated for use in various chronic conditions, further research is needed to fully understand their unique benefits and limitations in oncology, allowing for better integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promise of Wearable Physical Activity Monitors in Oncology Practice. Beg, MS., Gupta, A., Stewart, T., et al.[2018]

In a study of 37 advanced cancer patients, using wearable activity monitors provided objective data that correlated strongly with traditional performance status assessments, indicating that more steps taken daily were associated with better performance status.

Each additional 1000 steps per day was linked to significantly lower odds of adverse events, hospitalizations, and even reduced risk of death, suggesting that monitoring physical activity could help predict important clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. Gresham, G., Hendifar, AE., Spiegel, B., et al.[2020]

A systematic review of 14 studies found a weak-to-moderate positive association between physical activity measured by wearable activity monitors (WAMs) and performance status (PS) in cancer patients, indicating that more activity may correlate with better performance.

Conversely, there was a weak-to-moderate negative association between sedentary behavior (SB) metrics from WAMs and PS, suggesting that less sedentary time could be linked to improved performance, but WAM data should not replace physician assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between wearable activity monitor metrics and performance status in oncology: a systematic review. Kos, M., Pijnappel, EN., Buffart, LM., et al.[2022]

A systematic review of 199 studies involving 18,513 oncology patients found that wearable technologies are primarily used for rehabilitation (111 studies), treatment monitoring (68 studies), and prognostication (20 studies), highlighting their versatility in cancer care.

Wearable devices, such as ActiGraph and Fitbit, effectively measure physical activity and adherence, with 74% of studies reporting adherence rates over 80%, suggesting that these technologies can significantly support patient management and rehabilitation in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Wearable Devices in Oncology Patients: A Systematic Review. Chow, R., Drkulec, H., Im, JHB., et al.[2023]

Wearable activity monitors, like ActiGraph accelerometers and Fitbits, are generally accepted and effective tools for increasing physical activity levels among cancer survivors, as shown in a review of 28 studies involving both active treatment and post-treatment individuals.

While these devices successfully motivate short-term increases in physical activity, the benefits tend to decrease over time, highlighting the need for further research to enhance the long-term sustainability of these technologies in supporting ongoing physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. Keats, MR., Yu, X., Sweeney Magee, M., et al.[2023]

Cancer survivors who used wearable activity trackers (WATs) daily engaged in significantly more moderate to vigorous physical activity (MVPA), averaging 202 minutes per week, compared to 132 minutes for non-daily users and 88 minutes for non-users.

Daily WAT use was associated with a 3.53 times higher amount of MVPA, suggesting that these devices can effectively enhance exercise motivation and help survivors meet recommended physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The frequency of using wearable activity trackers is associated with minutes of moderate to vigorous physical activity among cancer survivors: Analysis of HINTS data. De La Torre, SA., Pickering, T., Spruijt-Metz, D., et al.[2023]

In a pilot study involving 23 patients undergoing radiotherapy, the use of activity trackers was well-accepted, with high compliance rates (92% of days tracked) among the 19 patients who completed the trial.

Decreases in physical activity during radiotherapy were associated with the onset of side effects and declines in quality of life, suggesting that monitoring activity could help identify patients needing early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of physical activity monitoring in cancer patients during radiotherapy, the GIROfit phase 2 pilot trial. Boeke, S., Hauth, F., Fischer, SG., 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]

Citations

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

Wearable activity monitors in oncology trials: Current use of an emerging technology. [2019]

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

Promise of Wearable Physical Activity Monitors in Oncology Practice. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

The association between wearable activity monitor metrics and performance status in oncology: a systematic review. [2022]

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

The Use of Wearable Devices in Oncology Patients: A Systematic Review. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The frequency of using wearable activity trackers is associated with minutes of moderate to vigorous physical activity among cancer survivors: Analysis of HINTS data. [2023]

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

Acceptance of physical activity monitoring in cancer patients during radiotherapy, the GIROfit phase 2 pilot trial. [2022]

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

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