Activity Monitoring for Cancer Performance Status

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how fitness trackers, like Fitbits, can help assess cancer patients' progress during treatment. By tracking movement, heart rate, and other metrics, researchers aim to gain a clear picture of a patient's health and detect warning signs early. This approach can be particularly beneficial for those in early-phase cancer trials. The trial suits cancer patients participating in specific USC/Norris therapeutic trials who own a smartphone and are willing to wear a tracker and share daily symptom updates. As an unphased study, this trial offers patients a unique opportunity to contribute to innovative research that could enhance cancer care.

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.

What prior data suggests that movement and fitness trackers are safe for cancer patients?

Research shows that movement and fitness trackers, such as Fitbits, are safe for people with cancer. These devices help monitor physical activity and other health metrics. Studies have found that cancer patients generally accept wearing these trackers.

In one study, testing physical performance, including the use of these trackers, proved safe for patients undergoing cancer treatment. Another analysis demonstrated that wearable devices helped improve physical activity and health outcomes.

Overall, evidence suggests that fitness trackers do not pose significant safety concerns for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using movement and fitness trackers for cancer performance status because they offer a non-invasive way to monitor a patient's physical health continuously. Unlike traditional assessments that rely on periodic clinical visits and subjective reporting, these devices provide real-time data on physical activity, sleep patterns, and overall well-being. This continuous monitoring could lead to more personalized and timely interventions, potentially improving patient outcomes and quality of life. The use of smartphone-based PRO diaries adds another layer of insight by capturing patient-reported outcomes like fatigue and social isolation, which are often overlooked in conventional treatment approaches.

What evidence suggests that movement and fitness trackers are effective for determining cancer performance status?

This trial will use wearable activity trackers, such as Fitbits, to monitor movement and assess the health of cancer patients. Studies have shown that these trackers can encourage increased activity, both in clinical settings and beyond. Research suggests these devices reliably monitor movement, aiding in understanding cancer patients' health. For these patients, trackers capture daily activity levels more accurately than older methods. Previous studies indicate that data from these trackers can offer important insights into a patient's risk of health issues or the need for hospital care. Overall, these trackers provide a clearer picture of a cancer patient's health and activity levels. ^{2 4 5 6 7}

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/CCI.20.00117

Feasibility of Fitness Tracker Usage to Assess Activity ... This study was designed to test the feasibility of using a fitness tracker (Fitbit Charge [FC]) to obtain PA data in patients with CRC ...

2. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000178

A pilot multicenter study from the Alliance for Clinical Trials in ... Wearable sensor-based performance status assessment in cancer: A pilot multicenter study from the Alliance for Clinical Trials in Oncology (A19_Pilot2).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2095254621000909

Effect and feasibility of wearable physical activity trackers ... Supervised exercise interventions have been shown to be effective for increasing physical activity levels and improving health outcomes in cancer populations.

4. thelancet.com thelancet.com/journals/landig/article/PIIS2589-75002200111-X/fulltext

Effectiveness of wearable activity trackers to increase ... Activity trackers appear to be effective at increasing physical activity in a variety of age groups and clinical and non-clinical populations.

5. startresearch.com startresearch.com/wearable-technology-in-early-phase-cancer-trials/

Wearable Technology in Early-Phase Cancer Trials In a study of advanced cancer patients, clinician-assessed ECOG scores showed poor concordance with objective activity data, such as walking distance, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8464563/

The association between wearable activity monitor metrics ... Pooled safety and efficacy analysis ... Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02659358

Evaluating the Use of Wearable Biosensors and PROs to ... The purpose of this study is to evaluate the association between wearable biosensor data, performance status and patient-reported outcomes in cancer ...