A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Hsiao-Lan Wang
hw3@uab.edu
317-658-2275
Time Frame
Start Date: 2020-08-21
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 150
Treatments
Experimental: PAfitME
For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention.
No_intervention: Attention Control
For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch).
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov