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Exergaming for Head and Neck Cancer

N/A

Recruiting

Led By Hsiao-Lan Wang, Ph.D.

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to communicate

Patients must be 18 years or older

Must not have

Patients will be excluded if they have a history of seizures or loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 and week 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an intervention to help head and neck cancer patients overcome barriers to physical activity during the first 6 months after their treatment. The intervention includes FaceTime calls and home visits, and uses commercially available exergaming platforms (Nintendo Switch). The trial will compare the experimental group receiving the intervention to an attention control group, and will evaluate the effect of the intervention on fatigue, musculoskeletal pain, functional status, and quality of life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves physical activity through exergaming, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can communicate effectively.

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I am 18 years old or older.

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

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I experience moderate to severe fatigue or pain.

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I have experienced moderate fatigue or pain, rating it 4 or higher in the past week.

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I am mostly able to care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had seizures or lost consciousness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).

Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).

Secondary study objectives

Objective Functional Status will be measured by 2-minute walk test.

Objective Functional Status will be measured by Timed up and go.

Objective Functional Status will be measured by chair sit and reach.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PAfitMEExperimental Treatment1 Intervention

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

Group II: Attention ControlActive Control1 Intervention

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

0 / 7Eligibility criteria met