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

NCT07715344 | Completed Early Phase 1

• 2 other identifiers: IRB-3000083962025171
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptom Management; Young Adult Cancer; Physical Activity; Gaming; Behavior Change Interventions

Keywords

cancer; symptom; young adult cancer; physical activity; gaming; behavior change intervention

Outcome Measures

Primary Outcomes (1)

• Change 6-minute walk test

  6-minute walk. The distance (in meters) walked in 6 minutes is measured.

  Baseline and Week 12

Study Arms (2)

PAfitME™ Condition

EXPERIMENTAL

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™

Usual Care Condition

NO INTERVENTION

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.

Interventions

PAfitME™ BEHAVIORAL

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.

PAfitME™ Condition

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• no cancer diagnosis
• no participation of exercise programs

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hsiao-Lan Wang, PhD, RN, FAAN

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: November 20, 2023
• Primary Completion: May 14, 2026
• Study Completion: May 14, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)