Actively Recruiting
A Motion Exergaming Approach for Symptom Management: HNC
Led by University of Alabama at Birmingham · Updated on 2025-10-15
150
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Motion Exergaming Approach for Symptom Management: HNC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with head and neck cancer (tumor sites in the head and neck area)
- 18 years or older
- Able to understand English
- Able to communicate
- Karnofsky Performance Status (KPS) score of 60% or higher
- Cleared by their healthcare provider to resume low to moderate intensity physical activity
- Have fatigue or pain of moderate severity or greater (score of 4 or higher on a 0-10 scale in the past week)
You will not qualify if you...
- Currently hospitalized
- In hospice care
- History of seizures or loss of consciousness
- Cognitively impaired, defined as making 3 or more errors on a 6-item cognitive screener (including orientation and recall questions)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
H
Hsiao-Lan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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