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

Trial Summary

What is the purpose of this trial?

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 after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Nintendo Switch). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data.

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 data supports the effectiveness of the treatment PAfitME for head and neck cancer?

Research shows that physical activity can improve quality of life for head and neck cancer patients, and personalized exercise programs are being explored for their feasibility and acceptability. While specific data on PAfitME is not available, similar exercise interventions have shown promise in enhancing quality of life and managing symptoms. ^{1 2 3 4 5}

Is exergaming safe for people with cancer?

There is limited information on the safety of exergaming specifically for cancer patients, but general exercise interventions in cancer care are being studied for potential harms. A method called ExHaRM is being developed to better report any adverse outcomes (unwanted effects) from exercise in cancer patients, which suggests that safety is being carefully considered in these studies. ^{1 2 6 7 8}

How is the PAfitME treatment different from other treatments for head and neck cancer?

The PAfitME treatment is unique because it uses personalized fitness-graded motion exergames, which are video games that require physical activity, to encourage exercise in a fun and engaging way. This approach is different from traditional exercise programs because it is tailored to each individual's fitness level and can be more motivating and enjoyable. ^{1 2 3 5 9}

Research Team

Hsiao-Lan Wang, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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 am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2023]

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

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Participation in sport and physical activity in head and neck cancer survivors: associations with quality of life. [2017]

5. United States 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. [2009]

6. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

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

Real-time visual activity feedback for physical activity improvement in breast and colon cancer patients. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Safety and feasibility of cardiopulmonary exercise testing in head and neck cancer survivors. [2023]