No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
150 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for people who have been diagnosed with head and neck cancer and are recovering from treatment. Participants will take part in a personalized exercise program using video calls and gaming platforms to help manage fatigue and pain.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with head and neck cancer.
I am 18 years or older.
I can understand English.
I can communicate.
I have a Karnofsky Performance Status score of 60% or higher.
My doctor has cleared me to resume low to moderate physical activity.
I have fatigue or pain that is at least moderate.
You may not be able to join if
I am currently hospitalized.
I am receiving hospice care.
I have a history of seizures or loss of consciousness.
I have cognitive impairment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 platfor…
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.
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Eligibility Criteria
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 cle…
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).
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