Physical Activity Monitoring for Brain Cancer

Overseen By Shiao-Pei S Weathers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive deficits, Major sensory deficits

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tracking steps can improve the quality of life for individuals with newly diagnosed glioma undergoing radiation therapy. Participants will wear either a Fitbit or a pedometer for six weeks to monitor daily activity (Step Count Monitoring). The research will explore whether increased activity can ease symptoms and enhance well-being. The trial seeks participants diagnosed with glioma who will receive radiation therapy and can use a smartphone with Wi-Fi access. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring physical activity in patients with brain cancer.

What prior data suggests that step count monitoring is safe for brain cancer patients?

Research shows that using Fitbits to count steps is generally safe and easy for most people. Studies on similar devices have found that people can use Fitbits without problems, and they help increase daily step counts. No reports of serious side effects have emerged from wearing Fitbits for this purpose.

These devices are popular and considered safe for tracking physical activity. Since this trial involves only counting steps and does not include any drugs or medical procedures, safety concerns are minimal. Participants will wear either a Fitbit or a pedometer, both common devices with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how physical activity monitoring can support brain cancer patients in ways traditional treatments don't address. Unlike chemotherapy or radiation, which directly target cancer cells, this trial uses step count monitoring with devices like FitBits and pedometers to encourage and track physical activity, potentially improving patients' overall well-being and recovery process. By focusing on a more holistic approach, researchers hope to uncover the benefits of integrating physical activity into cancer care, potentially setting a new standard for supportive treatment strategies.

What evidence suggests that step count monitoring is effective for improving quality of life in brain cancer patients?

Research has shown that Fitbit devices can increase daily step counts by about 950 steps on average. Regular use of step counters like Fitbits can help people maintain or increase their activity levels over time. In this trial, participants will be assigned to different groups for step count monitoring. Group II will use a Fitbit, while Group I will use a pedometer. For those with brain cancer, such as glioma, staying active can improve overall quality of life and help manage symptoms. Tracking steps with a Fitbit or a pedometer offers an easy way to monitor physical activity, which might help patients feel better during treatment. This practical method has shown promise in various health settings. ^{1 3 6 7 8}

Who Is on the Research Team?

Shiao-Pei S Weathers

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with a new glioma diagnosis who are starting at least 4 weeks of radiation therapy. Participants must have a good performance status, meaning they can carry out daily activities without significant help, be able to consent, own a smartphone, have Wi-Fi access, and not already use wearable activity trackers.

Inclusion Criteria

I have a glioma and will undergo radiation therapy for at least 4 weeks.

Able to provide informed consent

You need to have Wi-Fi available.

Exclusion Criteria

Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy while their physical activity is monitored using either a pedometer or a FitBit

6 weeks

Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Step Count Monitoring

Trial Overview The study is testing if using devices like FitBits or pedometers to monitor steps can help understand physical activity levels in patients undergoing radiation therapy for brain tumors. It aims to see if tracking steps could improve life quality and manage symptoms during treatment.

How Is the Trial Designed?

Group I: Group II (FitBit) Experimental Treatment 3 Interventions

Patients wear a FitBit for step count monitoring over 6 weeks.

Group II: Group I (pedometer) Active Control 3 Interventions

Patients wear a pedometer for step count monitoring over 6 weeks.

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

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 42 high-grade glioma patients using wrist-worn accelerometers, it was found that their moderate physical activity significantly decreased during radiotherapy, dropping from 69 to 16 minutes per day, highlighting the impact of treatment on physical function.

The data showed that HGG patients were much less active than healthy controls, walking only 1.32 hours per day compared to 2.91 hours, indicating a need for better monitoring and support to improve their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triaxial accelerometer-measured physical activity and functional behaviours among people with High Grade Glioma: The BrainWear Study. Dadhania, S., Pakzad-Shahabi, L., Mistry, S., et al.[2023]

An 18-week exercise intervention for adults with primary brain cancer was found to be safe, with no serious adverse events reported, and feasible, achieving high recruitment (80%) and retention (92%) rates.

Participants showed significant improvements in quality of life, functional well-being, and various physical fitness measures, indicating that exercise can be beneficial for individuals recovering from brain cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety, feasibility, and efficacy of an 18-week exercise intervention for adults with primary brain cancer - the BRACE study. Sandler, CX., Gildea, GC., Spence, RR., et al.[2023]

Monitoring physical activity using a Fitbit Zip is feasible in patients with advanced-stage lung cancer, with 67% adherence among participants.

Higher daily step counts were significantly correlated with improved quality of life and lower levels of depression, dyspnea, and pain, suggesting that increasing physical activity could enhance well-being in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Correlation Between Physical Activity and Quality of Life in Advanced Lung Cancer. Bade, BC., Brooks, MC., Nietert, SB., et al.[2018]

In a study of 50 patients with locally advanced non-small cell lung cancer (NSCLC) undergoing chemoradiation therapy, those categorized as inactive based on baseline step counts were significantly more likely to be hospitalized and less likely to complete their treatment on time.

Inactive patients had a median progression-free survival of only 5.3 months compared to 18.3 months for those who were moderately or highly active, indicating that baseline activity levels can be a strong predictor of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Step Counts: A New Prognostic Factor in Locally Advanced Non-Small Cell Lung Cancer? Ohri, N., Halmos, B., Bodner, WR., et al.[2020]

A 12-week study involving 80 advanced cancer patients showed that those receiving whole-body electromyostimulation (WB-EMS) training, in addition to nutritional support, had significant improvements in gait parameters, including increased stride length and gait velocity compared to the control group.

The WB-EMS group also experienced enhancements in overall physical function, as indicated by better performance in a six-minute walking test and increased skeletal muscle mass, suggesting that this combined approach may effectively improve the functional status of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of gait parameters and physical function in patients with advanced cancer participating in a 12-week exercise and nutrition programme: A controlled clinical trial. Schink, K., Gaßner, H., Reljic, D., et al.[2021]

Daily step count monitoring in older adults (aged 65+) undergoing treatment for metastatic prostate cancer was found to be feasible, with a high retention rate of 94% and a participation rate of 52.2%.

A 15% decline in daily steps was associated with the emergence of moderate to severe symptoms, showing good predictive validity (sensitivity of 81.8%), although it was less effective for predicting pain specifically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily physical activity monitoring in older adults with metastatic prostate cancer on active treatment: Feasibility and associations with toxicity. Feng, G., Parthipan, M., Breunis, H., et al.[2023]

Increased physical activity is linked to a lower risk of cancer occurrence and recurrence, making it a crucial measure in cancer rehabilitation and palliative care.

Accelerometers are highlighted as the most effective tool for measuring physical activity in cancer studies, as they provide detailed and objective data on the frequency, intensity, type, and duration of activity, yet they are underutilized in current research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guide to assessing physical activity using accelerometry in cancer patients. Broderick, JM., Ryan, J., O'Donnell, DM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7589007/

Fitbit-Based Interventions for Healthy Lifestyle Outcomes For Fitbit-based interventions, we found a statistically significant increase in daily step count (mean difference [MD] 950.54, 95% CI 475.89-1425.18; P<.001) ...

2. withpower.com withpower.com/trial/phase-glioma-4-2020-ffd9f

Physical Activity Monitoring for Brain Cancer This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation ...

3. cancer.jmir.org cancer.jmir.org/2025/1/e60034

Usability and Implementation Considerations of Fitbit and App ... Based on this measure, the mean daily step count was 7219 (SD 4418) at baseline and 6687 (SD 3183) at 12 weeks. Table 2. Mean (SD) number of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7571692/

Fitbit wear-time and patterns of activity in cancer survivors ... The study found wearable-tracker wear time to be high throughout the 24-week trial. Step count was maintained throughout the trial displaying ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1746809424009169

A correlation analysis between passively assessed gait ... This study explores the use of passively assessed gait initiation signal data (GISD) as a potential alternative to MRI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11875131/

Usability and Implementation Considerations of Fitbit and ... Outcome data for the intervention included Fitbit adherence and step counts over 3 months, usability ratings of the MyDataHelps app at 1 ...

7. nature.com nature.com/articles/s41746-018-0032-6

Wearable activity monitors to assess performance status ... Our trial demonstrates the feasibility of using wearable activity monitors to assess PS in advanced cancer patients and suggests their potential use to predict ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04186832

Step Count Monitoring as a Measure of Physical Activity in ... Evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (RT) at ...