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โ† Trials
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A Motion Exergaming Approach for Symptom Management: HNC

RecruitingNAAges 18 Years - anyAllUniversity of Alabama at Birmingham
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In plain words

What the trial is, and whether it could suit you

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 musc

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅmoderate severity; and A KPS score of \>= 60% has been used in previous exercise trials in the HNC population. This is equal to ECog scores โ‰ค 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 โ‰ฅ3 errors on a validated 6-item cognitive screener (3 items identifying the current year, month, and day; 3 items recalling 3 pre-selected objects).
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What it tests

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

1 site
University of Alabama at Birmingham
Birmingham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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