Exergaming for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Hsiao-Lan Wang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Hospitalized, Hospice, Seizures, Cognitive impairment

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with head and neck cancer become active after treatment. It tests a personalized exercise program using fitness games on the Nintendo Switch, known as a personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME). The researchers aim to determine if this program can reduce fatigue and pain while improving daily function and quality of life, compared to standard survivorship advice. Participants may qualify if they have completed cancer treatment, experience moderate fatigue or pain, and have been cleared by their doctor for light to moderate exercise. As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer recovery research and potentially enhance participants' quality of life.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this exergaming intervention is safe for head and neck cancer patients?

Research has shown that PAfitME, a personalized exercise program using motion-based video games, receives positive feedback from participants. These games aim to help head and neck cancer patients manage symptoms such as fatigue and pain after treatment. Early results from previous studies indicate positive health and behavior changes, suggesting the program is safe for participants.

The video games use a system like the Nintendo Switch, which is generally considered safe for most people. Although specific data on side effects for PAfitME is not available, the program combines safe activities like exercise and gaming, which typically carry low risks. This suggests the program is likely safe for most people, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAfitME intervention because it introduces an innovative way for head and neck cancer survivors to engage in physical activity through fitness-graded motion exergames. Unlike traditional rehabilitation methods that might involve standard exercise routines or physical therapy, PAfitME personalizes the experience, making exercise more engaging and adaptable to individual fitness levels. By using exergaming, this approach could potentially improve adherence to exercise regimes and enhance overall physical and mental well-being for survivors, offering a fun and interactive alternative to conventional methods.

What evidence suggests that this exergaming intervention is effective for head and neck cancer patients?

Studies have shown that physical activity can reduce tiredness and pain in individuals treated for head and neck cancer. In this trial, participants in the PAfitME group will follow a personalized exercise program featuring fun, interactive video games to encourage movement. This approach relies on the idea that enjoyment increases the likelihood of continued participation. Early results suggest that these exercise games can enhance quality of life and physical ability by boosting activity levels and motivation. While specific data for PAfitME is still being collected, similar research has shown promising results. ^{1 2 5 6 7}

Who Is on the Research Team?

Hsiao-Lan Wang, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with head and neck cancer who can understand English, communicate well, and have a moderate ability to perform daily activities (KPS score >=60%). They must be cleared for low to moderate physical activity by their doctor and experience at least moderate fatigue or pain. Those with cognitive impairments, hospitalization, hospice care, or seizure history are excluded.

Inclusion Criteria

I can communicate effectively.

I have been diagnosed with cancer in my head or neck area.

I experience moderate to severe fatigue or pain.

Exclusion Criteria

I have never had seizures or lost consciousness.

Patients will be excluded if they are in hospice care

Patients will be excluded if they are cognitively impaired, defined as making ≥3 errors on a validated 6-item cognitive screener (3 items identifying the current year, month, and day; 3 items recalling 3 pre-selected objects).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PAfitME intervention or attention control for 6 weeks

6 weeks

Mix of FaceTime calls and home visits

Follow-up

Participants are monitored for changes in fatigue, pain, and functional status

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)

Trial Overview

The study tests PAfitME—a personalized exercise program using motion exergames like Nintendo Switch—against standard survivorship education. It aims to see if PAfitME reduces fatigue and pain while improving functional status and quality of life in post-treatment head and neck cancer patients over six weeks.

How Is the Trial Designed?

Group I: PAfitME Experimental Treatment 1 Intervention

For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention.

Group II: Attention Control Active Control 1 Intervention

For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch).

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a pilot study of 48 head and neck cancer patients, those with higher pre-treatment physical activity levels reported better health-related quality of life (HRQL) at 12 months post-treatment, including less fatigue and pain.

The study found that pre-treatment physical activity, measured objectively with accelerometers, was positively correlated with improvements in physical function and overall HRQL over time, suggesting that maintaining higher activity levels before treatment may benefit long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study using pre-treatment physical activity level to predict long-term health-related quality of life in patients with head and neck cancer. Tuomi, L., Magnusson-Sandkvist, J., Fridolfsson, J., et al.[2023]

A study of 90 outpatients with head and neck cancer revealed that many patients lack specific preferences for exercise counseling and variability, indicating a potential area for tailored support.

Patients showed a preference for exercising outdoors, in the morning, and alone, with their quality of life influencing these preferences, suggesting that personalized exercise plans could enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Rogers, LQ., Malone, J., Rao, K., et al.[2009]

A biofeedback device significantly improved physical activity levels in 19 cancer patients, increasing their daily activity counts by 21% and moderate to vigorous physical activity by 9% after receiving real-time visual feedback.

After using the biofeedback device, the physical activity levels of cancer patients became nearly equal to those of 20 age-matched healthy controls, indicating the device's effectiveness in promoting activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time visual activity feedback for physical activity improvement in breast and colon cancer patients. Gabrys, L., Sperzel, S., Bernhoerster, M., et al.[2019]

The cardiopulmonary exercise test (CPET) was found to be safe and feasible for evaluating head and neck cancer survivors, with only minor issues leading to test termination in a few participants.

Survivors demonstrated significantly lower cardiorespiratory fitness, achieving a mean peak oxygen uptake that was 34% below predicted levels, highlighting the need for tailored exercise programs to improve their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of cardiopulmonary exercise testing in head and neck cancer survivors. Midgley, AW., Levy, AR., Cunha, FA., et al.[2023]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

A supervised exercise program for patients with head and neck cancer, involving 144 participants, aims to prevent loss of lean body mass and improve quality of life, with sessions scheduled over 12 weeks before or after radiotherapy.

The pilot study indicates that the exercise program is feasible and safe, but attendance decreased over time, highlighting the need for strategies to enhance patient engagement and adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. Rodriguez-Arietaleanizbeaskoa, M., Mojas Ereño, E., Arietaleanizbeaskoa, MS., et al.[2023]

This feasibility study involves 70 patients with head and neck cancer participating in an 8-week personalized exercise program, aiming to assess the program's acceptability and retention within standard care.

The study will evaluate various outcomes, including fatigue, quality of life, and physical fitness, to inform the design of a future randomized controlled trial, indicating a potential shift towards personalized exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACTivity as medicine In Oncology for Head and Neck (ACTIOHN): Protocol for a feasibility study investigating a patient-centred approach to exercise for people with head and neck cancer. Midgley, AW., Levy, AR., Rogers, SN., et al.[2023]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Before treatment for head and neck cancer, 62.2% of patients met UK physical activity guidelines, but this dropped to 40.1% after treatment, indicating a significant decline in physical activity levels post-diagnosis.

There is a positive correlation between post-treatment physical activity and quality of life, suggesting that engaging in physical activity may help improve the well-being of patients after head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in sport and physical activity in head and neck cancer survivors: associations with quality of life. Sammut, L., Fraser, LR., Ward, MJ., et al.[2017]

Citations

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reporter.nih.gov

reporter.nih.gov/project-details/10980419

Project Details - NIH RePORTER

Project Summary/Abstract Among head and neck cancer (HNC) patients, 92% report fatigue and 73% have pain. A 10% increase in fatigue or pain is associated ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04632654

Study Details | NCT04632654 | A Motion Exergaming ...

This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months ...

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cancer.gov

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A Motion Exergaming Approach for Symptom Management

PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime ...

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trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/259422

A Motion Exergaming Approach for Symptom Management

PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix ...

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prevention.cancer.gov

prevention.cancer.gov/funding-and-grants/funded-grants/R01CA244947

Funded Grants | Division of Cancer Prevention

PAfitME, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and ...

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prevention.cancer.gov

prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04632654

A Motion Exergaming Approach for Symptom Management

PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls ...

7.

par.nsf.gov

par.nsf.gov/servlets/purl/10293338

A Behavioral Physical Activity Intervention to Manage ...

Health outcomes were CRF, ADL dependence, and fitness performance. Behavioral outcomes were exergame adherence. Results: Positive health and behavioral outcomes ...