Reducing Health Disparity of Physical Functioning Among Young Adult Cancer Patients of Color

The purpose of the study is to pilot test of PAfitME™ among (1) young adults (YA) cancer patients of color (POC) (Analytic Sample [N=36] after attrition of 30%) and (2) YA cancer patients of White (POW) (Analytic Sample [N=36] after attrition of 30%).

Aim 1: Evaluate Exergame Grading Scheme (EGS) validity when EGS is tested in relationship to standard lab tests (Bruce Treadmill Protocol and isometric/isokinetic dynamometry) and field fitness tests (6-minute walk test, handgrip, and Chair Stand Test).

Aim 2a: Evaluate the feasibility (enrollment rate [% of eligible patients], attrition rate [% in either intervention or control group], adherence rate [% of completed prescribed exergame minutes]), safety (numbers of adverse events), and acceptability (satisfaction score & exit qualitative interviews) of PAfitME™.

Aim 2b: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POC.

Aim 2c: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POW.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Symptom Management; Young Adult Cancer; Gaming; Behavior Change Interventions
• Intervention / Treatment: Behavioral: PAfitME™

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. post-cancer treatment
2. age of 18-39 years old
3. ability to read and speak English
4. medical clearance of stress test (Bruce treadmill protocol)
5. no participation in an exercise program
6. complaint of functional decline after cancer diagnoses
7. complaint of fatigue or/and pain symptoms after cancer treatment.

Exclusion Criteria:

1. no cancer diagnosis
2. no participation of exercise programs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAfitME™ Condition; PAfitME™ Condition. Three types of sessions will be delivered through FaceTime/Zoom (telehealth) over 12 weeks. A Nintendo Switch console and iPad will be provided at week 0 home visit during the fitness tests. Three Types: (1) Setup session (via FaceTime/Zoom). (2) Start/progress sessions (via FaceTime/Zoom). (3) Coaching Sessions (via FaceTime/Zoom).	Behavioral: PAfitME™; PAfitME™, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principle of adaptation (cardiorespiratory and skeletal muscle functional adaptation and remodeling in response to frequent physical activity stimuli). PAfitME™ is personalized to the patient's PA barriers: (1) fitness capacities, (2) PA health beliefs (self-efficacy and enjoyment), and (3) fatigue/pain levels. PAfitME™, delivered via FaceTime/Zoom calls, uses commercially available exergaming platforms (Nintendo). Innovative features of PAfitME™ include personalizing the exergame platform to deliver (1) a home-based telehealth intervention to overcome PA barriers in order to improve PA self-efficacy, PA enjoyment, and subsequent PA behavior; (2) a technological approach with dynamic visual feedback to assure PA accuracy and competence; and (3) a real-time assessment of individual exergame performanance.
No Intervention: Usual Care Condition; The participants in the usual care group will have routine care from their healthcare providers. They will receive the National Cancer Institute Cancer Survivorship Booklet. There will be two FaceTime/Zoom visits: one is the introduction of the study, and the other is the conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 6-minute walk test	6-minute walk. The distance (in meters) walked in 6 minutes is measured.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Oncology Nursing Society
• Investigators: Principal Investigator: Hsiao-Lan Wang, PhD, RN, FAAN, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): May 14, 2026
• Study Completion (Actual): May 14, 2026

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; cancer; symptom; gaming; behavior change intervention; young adult cancer
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity
• Other Study ID Numbers: IRB-300008396; 2025171 (Other Identifier: Oncology Nursing Foundation (20221, RE42))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No