Recruiting

SABC

Sponsor:

West Virginia University

Code:

NCT06960720

Conditions

Breast Cancer

Fatigue

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resistance Exercises

Study Details

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

Conditions

Breast Cancer

Fatigue

Study ID

NCT06960720

Start date

Oct 13, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Strength 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.

active comparator: Strength 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.

Interventions

Resistance Exercises

Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan.

Primary outcome measure

  • Dropout Rate - Lower SES [ Time Frame: 3 Months ]
  • Dropout Rate - Higher SES [ Time Frame: 3 Months ]
  • Overall Dropout Rate [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Megan Clark, MD

304-974-3912megan.clark3@hsc.wvu.edu

McKinzey K Dierkes, DPT

mkd00001@mix.wvu.edu

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Tara Riddle

3049065228tlr0011@hsc.wvu.edu

Principal Investigator:

Megan Clark, MD

More Information

Sponsor

West Virginia University

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • Strength After Breast Cancer
  • Allostatic load
  • Cancer Related Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2025-10-31.