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

NCT ID: NCT06960720

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Resistance Exercises

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Resistance Exercises

Intervention Type: OTHER

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

Interventions

Resistance Exercises

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Megan Clark

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan Clark, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan Clark, MD

Role: CONTACT

megan.clark3@hsc.wvu.edu

304-974-3912

McKinzey K Dierkes, DPT

Role: CONTACT

mkd00001@mix.wvu.edu

Facility Contacts

Tara Riddle

Role: primary

tlr0011@hsc.wvu.edu

3049065228

Other Identifiers

2501103633

Identifier Type: -

Identifier Source: org_study_id