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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWest Virginia University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Resistance Exercises

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Strength After Breast Cancer (SABC) Lower SESActive comparator 1 intervention
Group B: Strength After Breast Cancer (SABC) Higher SESActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dropout Rate - Lower SES

Percentage of participants in the lower SES group who drop out of the program

Time frame
3 Months
2

Dropout Rate - Higher SES

Percentage of participants in the higher SES group who drop out of the program

Time frame
3 Months
3

Overall Dropout Rate

Percentage of participants who drop out of the program.

Time frame
3 Months

Secondary outcomes

1

Adherence Rate - Lower SES

Percentage of participants in the lower SES group completing ≥ 75% of intervention activities and all scheduled assessments.

Time frame
3 Months
2

Adherence Rate - Higher SES

Percentage of participants in the higher SES group completing ≥ 75% of intervention activities and all scheduled assessments

Time frame
3 Months
3

Overall Adherence Rate

Percentage of participants completing ≥ 75% of intervention activities and all scheduled assessments.

Time frame
3 Months

Other outcomes

1

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.

Time frame
Baseline to 3 Month follow up
2

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.

Time frame
Baseline to 3 Month follow up
3

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.

Time frame
Baseline to 3 Month follow up
4

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).

Time frame
Baseline to 3 Month Follow Up

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