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A Motion Exergaming Approach for Symptom Management: HNC

A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

To be eligible for this study, patients must be:

1. diagnosed with head and neck cancer (Tumor sites in the head and neck area);
2. 18 years or older;
3. able to understand English;
4. able to communicate;
5. have a Karnofsky Performance Status (KPS) score of \>= 60%;
6. be cleared by their provider to resume low to moderate intensity PA;
7. have fatigue or pain of ≥moderate severity; and

A KPS score of \>= 60% has been used in previous exercise trials in the HNC population. This is equal to ECog scores ≤ 2.

Moderate fatigue or pain severity is defined as a worst score in the past week of \>= 4 on a 0-10 scale.

Patients receiving immunotherapy are not excluded from participating in the study.

Exclusion Criteria:

Patients will be excluded if they

1. are hospitalized;
2. are in hospice care;
3. have a history of seizures or loss of consciousness; or
4. 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).

About the study

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.

What is being tested

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

Sponsor: University of Alabama at Birmingham · Participants: 150 · Started: Aug 21, 2020

Contact the study team

• Hsiao-Lan Wang · Phone: 317-658-2275

Official record on ClinicalTrials.gov — NCT04632654

Locations in the U.S.

Conditions

• Head and Neck Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.