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임상시험 NCT06960720은(는) 유방암, 피로에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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카드 뷰

Lifting More Than Weights: Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management

모집중
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임상시험 NCT06960720은(는) 유방암, 피로에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 10월 13일에 시작되어 60명의 참여자를 모집하고 있습니다. 웨스트버지니아 대학교이(가) 진행하며, 2027년 8월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 10월 31일에 갱신되었습니다.
간단한 개요

The long-term goal of this project is to improve the implementation of tailored resistance exercise interventions for Appalachian breast cancer survivors. To achieve this goal, the primary objective is to enhance the understanding of how biological, psychological, and social factors interact to influence readiness for behavior change around resistance exercise in this unique population. The primary aim is to evaluate the feasibility of delivering the Strength After Breast Cancer (SABC) program, focusing on how socioeconomic status (SES) and allostatic load (AL) scores influence adherence and dropout rates. The Investigators will also further examine how self-efficacy, outcome expectations, and social support influence behavior change related to resistance exercise participation. The central hypothesis is that participants with lower SES will report geographic or financial constraints, receive reduced support from family or peers, have low confidence in their ability to exercise, and demonstrate lower adherence rates.

Participants will:

  • Use a clear, step-by-step guide for safe, progressive strength training using a resistance exercise program tailored specifically for breast cancer survivors for a duration of 3 months
  • Keep an exercise log and complete questionnaires
공식 제목

Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management

질환/상태
유방암피로
기타 연구 식별자
  • 2501103633
NCT 번호
실제 연구 시작일
2025-10-13
최신 업데이트 게시
2025-10-31
예상 연구 완료일
2027-08
계획된 등록 인원
60
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Strength After Breast Cancer
Allostatic load
Cancer Related Fatigue
주요 목적
지지요법
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
활성 대조군Strength After Breast Cancer (SABC) Lower SES
Strength after Breast Cancer (SABC) is an evidence-based exercise program that improves body composition, body image, strength, and upper body using initial supervised sessions followed by unsupervised sessions with follow-up as needed.
저항 운동
Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan.
활성 대조군Strength After Breast Cancer (SABC) Higher SES
Strength after Breast Cancer (SABC) is an evidence-based exercise program that improves body composition, body image, strength, and upper body using initial supervised sessions followed by unsupervised sessions with follow-up as needed.
저항 운동
Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan.
주요결과변수
결과변수측정값 설명시간 범위
Dropout Rate - Lower SES
Percentage of participants in the lower SES group who drop out of the program
3 Months
Dropout Rate - Higher SES
Percentage of participants in the higher SES group who drop out of the program
3 Months
Overall Dropout Rate
Percentage of participants who drop out of the program.
3 Months
이차결과변수
결과변수측정값 설명시간 범위
Adherence Rate - Lower SES
Percentage of participants in the lower SES group completing ≥ 75% of intervention activities and all scheduled assessments.
3 Months
Adherence Rate - Higher SES
Percentage of participants in the higher SES group completing ≥ 75% of intervention activities and all scheduled assessments
3 Months
Overall Adherence Rate
Percentage of participants completing ≥ 75% of intervention activities and all scheduled assessments.
3 Months
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
  • Subjects must have histologically or cytologically confirmed Breast Cancer; any tumor molecular subtype can be enrolled.
  • Subjects must have been diagnosed with non-metastatic breast cancer, defined as stage 0, I, II, or III (according to the American Joint Committee on Cancer Tumor, Node, Metastasis staging system), and must be between one and three years post-diagnosis at the time of enrollment. With treatment being received from the West Virginia University (WVU) Cancer Institute.
  • Any severity or report of fatigue. This can be done through a subjective report documented by any healthcare professional or through a screening tool like the enhanced distress thermometer.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects who are pregnant (first or second trimester) or breastfeeding must receive additional approval from their obstetrics and gynecology physician for participation. Only individuals with a singleton pregnancy (no multiple gestations) will be eligible for participation. Pregnant participants must be in their first or second trimester at the time of enrollment to ensure they can complete the full three-month program before childbirth. Multiple gestations are associated with higher risks of pregnancy complications, increased physical limitations, and a greater likelihood of preterm delivery, which may prevent completion of the program.

  • Male biological gender. Males will be excluded from the study due to the rarity of male breast cancer and the variability gender creates on AL scores.
  • Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, active alcoholism, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects with pregnancy beyond the second trimester at the time of enrollment, as later stages of pregnancy may prevent completion of the full three-month program.
  • Subjects who are pregnant with multiple gestations (e.g., twins, triplets, or higher-order pregnancies) due to the increased risk of pregnancy-related complications, physical limitations, and the likelihood of preterm delivery, which may interfere with program completion.
  • Subjects whose self-reported household income is above or below the median household income in Appalachia ($61,688) and for whom the target enrollment of 30 participants in that respective SES group (higher or lower) has already been met at the time of screening, as representation of both SES groups is required for the study.
연구 책임자
Megan Clark, 책임연구자, Associate Professor, West Virginia University
연구 대표 연락처
연락처: Megan Clark, MD, 304-974-3912, [email protected]
연락처: McKinzey K Dierkes, DPT, [email protected]
1 1개국에 임상시험 장소

West Virginia

West Virginia University, Morgantown, West Virginia, 26506, United States
Tara Riddle, 연락처, 3049065228, [email protected]
Megan Clark, MD, 책임연구자
모집중