NCT04632654Recruiting

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 150 (estimated)
First submitted: 29 Sept 2020
Start date: 21 Aug 2020
Primary completion date: 30 Nov 2026
Lead sponsor: University of Alabama at Birmingham
Diseases: Head and neck cancer
NCT number: NCT04632654

What you commit to

Study type: Interventional
Planned participants: 150
From 21 Aug 2020 to the primary completion date, 30 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

have a history of seizures or loss of consciousness; or

Other

Patients will be excluded if they
are hospitalized;
are in hospice care;
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).

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Alabama at Birmingham Coordinator of this site? Confirm its status	Birmingham	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.