Symptom ManagementEarly Phase 1NCT07715344
Reducing Health Disparity of Physical Functioning Among Young Adult Cancer Patients of Color
A Early Phase 1 study testing PAfitME™ in people with Symptom Management and Young Adult Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Symptom Management, Young Adult Cancer, Physical Activity
- What is being tested?
- PAfitME™
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 14 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- no cancer diagnosis
- no participation of exercise programs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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).
Read more
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
- Being tested
- PAfitME™
- Keywords
- cancer, symptom, young adult cancer, physical activity, gaming, behavior change intervention
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAfitME™Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 6-minute walk test
6-minute walk. The distance (in meters) walked in 6 minutes is measured.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Nov 2023
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ManagementStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Principal investigator, Hsiao-Lan Wang, University of Alabama at Birmingham
- Investigators
- Hsiao-Lan Wang, PhD, RN, FAAN, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715344
- Sponsor's protocol ID
- IRB-300008396
- Other IDs
- 2025171
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparity of Physical Functioning Among Young Adult Cancer Patients of Color
- ClinicalTrials.gov ID
- NCT07715344
- Acronym / sponsor ID
- IRB-300008396
- Conditions
- Symptom Management, Young Adult Cancer, Physical Activity, Gaming, Behavior Change Interventions
- Keywords
- cancer, symptom, young adult cancer, physical activity, gaming, behavior change intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAfitME™ Condition | Experimental | Behavioral: PAfitME™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). |
| 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- no cancer diagnosis
- no participation of exercise programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PAfitME™ Condition |
Primary outcome
Change 6-minute walk test
Time frame: Baseline and Week 12
6-minute walk. The distance (in meters) walked in 6 minutes is measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Symptom Management
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Lan Wang, PhD, RN, FAAN principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PAfitME™ in people with Symptom Management and Young Adult Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change 6-minute walk test (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.