A Motion Exergaming Approach for Symptom Management: HNC

Summary

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.

Eligibility

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).

Conditions2

Locations1 site

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