Clinical trial NCT06960720: Lifting More Than Weights: Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Official title: Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Fatigue
Keywords: Strength After Breast Cancer
Allostatic load
Cancer Related Fatigue
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: Dropout Rate - Lower SES
timeFrame: 3 Months
measure: Dropout Rate - Higher SES
timeFrame: 3 Months
measure: Overall Dropout Rate
timeFrame: 3 Months
Secondary outcomes:
measure: Adherence Rate - Lower SES
timeFrame: 3 Months
measure: Adherence Rate - Higher SES
timeFrame: 3 Months
measure: Overall Adherence Rate
timeFrame: 3 Months
Other outcomes:
measure: FACIT-F - (Lower SES)
timeFrame: Baseline to 3 Month follow up
measure: FACIT-F - (Higher SES)
timeFrame: Baseline to 3 Month follow up
measure: FACIT-F - Overall Change in Score
timeFrame: Baseline to 3 Month follow up
measure: Allostatic Load (AL) Score- (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Allostatic Load (AL) Score - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Allostatic Load (AL) Score - Overall Change in score
timeFrame: Baseline to 3 Month Follow Up
measure: Stages of Change Exercise Continuous Measure - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Stages of Change Exercise Continuous Measure- (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Stages of Change Exercise Continuous Measure- Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
measure: Self-Efficacy for Exercise - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Self-Efficacy for Exercise - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Self-Efficacy for Exercise - Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
measure: Bellarmine Norton Assessment Tool (BNAT) Score - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Bellarmine Norton Assessment Tool (BNAT) Score - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Bellarmine Norton Assessment Tool (BNAT) Score - Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
measure: Grip Strength - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Grip Strength - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Grip Strength - Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) - Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
measure: Lymphedema Surveillance (L-Dex Score) - (Lower SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Lymphedema Surveillance (L-Dex Score) - (Higher SES)
timeFrame: Baseline to 3 Month Follow Up
measure: Lymphedema Surveillance (L-Dex Score) - Overall Change in Score
timeFrame: Baseline to 3 Month Follow Up
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Megan Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: