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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.

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 data supports the effectiveness of the treatment Step Count Monitoring for brain cancer?

Research shows that increasing physical activity, like monitoring step counts, is safe and beneficial for lung cancer patients, improving their quality of life. This suggests that similar benefits might be seen in brain cancer patients using step count monitoring. ^{1 2 3 4 5}

Is physical activity monitoring safe for people with brain cancer?

Research, such as the BRACE study, has looked into the safety of exercise interventions for adults with primary brain cancer, suggesting that monitoring physical activity is generally safe for humans. ^{1 3 6 7 8}

How does physical activity monitoring differ from other treatments for brain cancer?

Physical activity monitoring for brain cancer is unique because it uses wearable devices to track real-time physical activity, providing continuous and objective data. This approach differs from traditional treatments as it focuses on monitoring physical function and recovery, rather than directly treating the cancer itself. ^{1 2 6 7 8}

Research Team

Shiao-Pei S Weathers

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Daily Step Counts: A New Prognostic Factor in Locally Advanced Non-Small Cell Lung Cancer? [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

A guide to assessing physical activity using accelerometry in cancer patients. [2021]

3. England 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. [2023]

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

Assessing the Correlation Between Physical Activity and Quality of Life in Advanced Lung Cancer. [2018]

5. England 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. [2021]

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

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

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

Daily physical activity monitoring in older adults with metastatic prostate cancer on active treatment: Feasibility and associations with toxicity. [2023]

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

Triaxial accelerometer-measured physical activity and functional behaviours among people with High Grade Glioma: The BrainWear Study. [2023]