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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07715344
Enrollment
89
Registered
2026-07-20
Start date
2023-11-20
Completion date
2026-05-14
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALPAfitME™

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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
Oncology Nursing Society
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change 6-minute walk testBaseline and Week 126-minute walk. The distance (in meters) walked in 6 minutes is measured.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHsiao-Lan Wang, PhD, RN, FAAN

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026