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Clinical Trial NCT06960720 for Breast Cancer, Fatigue is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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West Virginia UniversityLifting More Than Weights: Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Clinical Trial NCT06960720 is an interventional study for Breast Cancer, Fatigue that is recruiting. It started on October 13, 2025 with plans to enroll 60 participants. Led by West Virginia University, it is expected to complete by August 1, 2027. The latest data from ClinicalTrials.gov was last updated on October 31, 2025.
Brief Summary
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
Official Title
Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Conditions
Breast CancerFatigueOther Study IDs
- 2501103633
NCT ID Number
Start Date (Actual)
2025-10-13
Last Update Posted
2025-10-31
Completion Date (Estimated)
2027-08
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Strength After Breast Cancer
Allostatic load
Cancer Related Fatigue
Allostatic load
Cancer Related Fatigue
Primary Purpose
Supportive Care
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStrength 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. | Resistance Exercises Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan. |
Active ComparatorStrength 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. | Resistance Exercises Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
West Virginia University54 active trials to exploreStudy Responsible Party
Megan Clark, Principal Investigator, Associate Professor, West Virginia University
Study Central Contact
Contact: Megan Clark, MD, 304-974-3912, [email protected]
Contact: McKinzey K Dierkes, DPT, [email protected]
1 Study Locations in 1 Countries
West Virginia
West Virginia University, Morgantown, West Virginia, 26506, United States
Tara Riddle, Contact, 3049065228, [email protected]
Megan Clark, MD, Principal Investigator
Recruiting