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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07715344
Phase
EARLY_PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Nov 20, 2023
Status verified
Jul 2026
Primary completion
May 14, 2026
Completion
May 14, 2026

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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).
  • 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.

Primary Outcome Measure

Change 6-minute walk test [ Time Frame: Baseline and Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-

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By research site
University of Alabama at Birmingham· Birmingham, AL

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