About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Resistance Exercises
Other interventionTwice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan.
Treatment groups
Trial outcomes
Primary outcomes
Dropout Rate - Lower SES
Percentage of participants in the lower SES group who drop out of the program
Dropout Rate - Higher SES
Percentage of participants in the higher SES group who drop out of the program
Overall Dropout Rate
Percentage of participants who drop out of the program.
Secondary outcomes
Adherence Rate - Lower SES
Percentage of participants in the lower SES group completing ≥ 75% of intervention activities and all scheduled assessments.
Adherence Rate - Higher SES
Percentage of participants in the higher SES group completing ≥ 75% of intervention activities and all scheduled assessments
Overall Adherence Rate
Percentage of participants completing ≥ 75% of intervention activities and all scheduled assessments.
Other outcomes
FACIT-F - (Lower SES)
Change in score of fatigue will be measured using the Functional Assessment of Chronic Illness-Fatigue (FACIT-F), fatigue subscale. This is a 13-item subscale of the FACIT-F questionnaire in which a higher score indicates less fatigue. Scores range from 0-52.
FACIT-F - (Higher SES)
Change in score of fatigue will be measured using the Functional Assessment of Chronic Illness-Fatigue (FACIT-F), fatigue subscale. This is a 13-item subscale of the FACIT-F questionnaire in which a higher score indicates less fatigue. Scores range from 0-52.
FACIT-F - Overall Change in Score
Change in score of fatigue will be measured using the Functional Assessment of Chronic Illness-Fatigue (FACIT-F), fatigue subscale. This is a 13-item subscale of the FACIT-F questionnaire in which a higher score indicates less fatigue. Scores range from 0-52.
Allostatic Load (AL) Score- (Lower SES)
Change in Allostatic Load score. AL score calculations will occur using cardiovascular, metabolic, and immune system biomarkers in the electronic health record (EHR). AL will be calculated by summing the number of biomarkers in the highest-risk quartile according using a range from 0 (low AL) to 10 (high AL).
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