Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04632654

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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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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