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.
연구 개요
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- no cancer diagnosis
- no participation of exercise programs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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). |
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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change 6-minute walk test
기간: Baseline and Week 12
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6-minute walk.
The distance (in meters) walked in 6 minutes is measured.
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Baseline and Week 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hsiao-Lan Wang, PhD, RN, FAAN, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은
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