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NCT04632654 · ClinicalTrials.gov registry record · NA
A Motion Exergaming Approach for Symptom Management: HNC
A NA study of Head and Neck Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04632654: Recruiting NA study of Head and Neck Cancer, sponsored by University of Alabama at Birmingham.
NCT04632654 is a NA study of Head and Neck Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632654, a NA study of Head and Neck Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
In the PROMIS Short Form v1.0-Fatigue, the 6 items ask about fatigue status, including fatigue severity and fatigue distress in the past 7 days. The scale ranges from 1 to 5. The higher the score, the worse the symptom. The mean score of 6 items will be calculated in the analysis to test the changes from baseline to week 6.
Conditions Studied
Interventions
- BEHAVIORAL A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What NCT04632654 shows while recruiting
NCT04632654 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) is the first listed.
NCT04632654 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04632654 about?
NCT04632654 is a clinical study titled "A Motion Exergaming Approach for Symptom Management: HNC". 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 delivere...
What is the current status of trial NCT04632654?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-21. Estimated completion is 2026-11-30.
What conditions does trial NCT04632654 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT04632654?
The interventions under investigation include: A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04632654?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04632654 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04632654's enrollment target sits among peer trials
150 60th of 250 higher than 187 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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