A Motion Exergaming Approach for Symptom Management: HNC
Recruiting now · Not applicable
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT04632654
- Run by
- University of Alabama at Birmingham
- People needed
- 150
- Starts
- 2020-08-21
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible for this study, patients must be:
- 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;
- have a Karnofsky Performance Status (KPS) score of >= 60%;
- be cleared by their provider to resume low to moderate intensity PA;
- 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.
You may not qualify if…
- Patients will be excluded if they
- are hospitalized;
- are in hospice care;
- have a history of seizures or loss of consciousness; or
- 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).
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.