West Virginia University
Morgantown, West Virginia, 26506, United States
Location status: Recruiting
NCT Number: NCT06960720
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
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Morgantown, West Virginia, 26506, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twice-weekly resistance exercises completed in 45 minutes using resistance bands and a physical therapy workout plan.
Time frame: 3 Months
Percentage of participants in the lower SES group who drop out of the program
Time frame: 3 Months
Percentage of participants in the higher SES group who drop out of the program
Time frame: 3 Months
Percentage of participants who drop out of the program.
Time frame: 3 Months
Percentage of participants in the lower SES group completing ≥ 75% of intervention activities and all scheduled assessments.
Time frame: 3 Months
Percentage of participants in the higher SES group completing ≥ 75% of intervention activities and all scheduled assessments
Time frame: 3 Months
Percentage of participants completing ≥ 75% of intervention activities and all scheduled assessments.
Time frame: Baseline to 3 Month follow up
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
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
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
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
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
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
Change in the Stages of Change Exercise Continuous Measure Score. This is a self-administered 24 item questionnaire to assess an individual's readiness to engage in regular physical activity. The items are categorized into different stages of readiness: Precontemplation, Contemplation, Preparation, Action, and Maintenance. Each item is rated on a Likert-type scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). There are stage scores (sum the responses for items within each stage) and a total score (sum the stage scores to get an overall readiness score). Higher scores in stages indicate a higher level of readiness of the participants.
Time frame: Baseline to 3 Month Follow Up
Change in the Stages of Change Exercise Continuous Measure Score. This is a self-administered 24 item questionnaire to assess an individual's readiness to engage in regular physical activity. The items are categorized into different stages of readiness: Precontemplation, Contemplation, Preparation, Action, and Maintenance. Each item is rated on a Likert-type scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). There are stage scores (sum the responses for items within each stage) and a total score (sum the stage scores to get an overall readiness score). Higher scores in stages indicate a higher level of readiness of the participants.
Time frame: Baseline to 3 Month Follow Up
Change in the Stages of Change Exercise Continuous Measure Score. This is a self-administered 24 item questionnaire to assess an individual's readiness to engage in regular physical activity. The items are categorized into different stages of readiness: Precontemplation, Contemplation, Preparation, Action, and Maintenance. Each item is rated on a Likert-type scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). There are stage scores (sum the responses for items within each stage) and a total score (sum the stage scores to get an overall readiness score). Higher scores in stages indicate a higher level of readiness of the participants.
Time frame: Baseline to 3 Month Follow Up
Change in score for the Self-Efficacy for Exercise (SEE) Scale. This scale is used to assess an individual's confidence in their ability to engage in regular physical activity. It is a 9-item self-administered questionnaire. Each item is rated on a 11-point Likert scale (0 = Not confident at all to 10 = Very confident). Higher scores indicate greater self-efficacy for exercise.
Time frame: Baseline to 3 Month Follow Up
Change in score for the Self-Efficacy for Exercise (SEE) Scale. This scale is used to assess an individual's confidence in their ability to engage in regular physical activity. It is a 9-item self-administered questionnaire. Each item is rated on a 11-point Likert scale (0 = Not confident at all to 10 = Very confident). Higher scores indicate greater self-efficacy for exercise.
Time frame: Baseline to 3 Month Follow Up
Change in score for the Self-Efficacy for Exercise (SEE) Scale. This scale is used to assess an individual's confidence in their ability to engage in regular physical activity. It is a 9-item self-administered questionnaire. Each item is rated on a 11-point Likert scale (0 = Not confident at all to 10 = Very confident). Higher scores indicate greater self-efficacy for exercise.
Time frame: Baseline to 3 Month Follow Up
Change in BNAT score. This is a clinical tool designed to measure physical function in individuals with cancer. It includes both self-reported and objective physical performance components. Each component of the BNAT is scored individually, and these scores are then combined to produce the total BNAT score. Scoring process: - Self-Reported Physical Activity: Rated on a Likert scale (e.g., 1 to 5), where higher scores indicate higher levels of physical activity. - Objective Tests: 2-Minute Step Test: The number of steps is converted into a score (e.g., 1 to 5); 30-Second Sit to Stand: The number of cycles is converted into a score (e.g., 1 to 5); Timed Arm Curl: The number of curls is converted into a score (e.g., 1 to 5); Timed Up and Go (TUG): The time taken is converted into a score (e.g., 1 to 5), with lower times indicating better performance.
Time frame: Baseline to 3 Month Follow Up
Change in BNAT score. This is a clinical tool designed to measure physical function in individuals with cancer. It includes both self-reported and objective physical performance components. Each component of the BNAT is scored individually, and these scores are then combined to produce the total BNAT score. Scoring process: - Self-Reported Physical Activity: Rated on a Likert scale (e.g., 1 to 5), where higher scores indicate higher levels of physical activity. - Objective Tests: 2-Minute Step Test: The number of steps is converted into a score (e.g., 1 to 5); 30-Second Sit to Stand: The number of cycles is converted into a score (e.g., 1 to 5); Timed Arm Curl: The number of curls is converted into a score (e.g., 1 to 5); Timed Up and Go (TUG): The time taken is converted into a score (e.g., 1 to 5), with lower times indicating better performance.
Time frame: Baseline to 3 Month Follow Up
Change in BNAT score. This is a clinical tool designed to measure physical function in individuals with cancer. It includes both self-reported and objective physical performance components. Each component of the BNAT is scored individually, and these scores are then combined to produce the total BNAT score. Scoring process: - Self-Reported Physical Activity: Rated on a Likert scale (e.g., 1 to 5), where higher scores indicate higher levels of physical activity. - Objective Tests: 2-Minute Step Test: The number of steps is converted into a score (e.g., 1 to 5); 30-Second Sit to Stand: The number of cycles is converted into a score (e.g., 1 to 5); Timed Arm Curl: The number of curls is converted into a score (e.g., 1 to 5); Timed Up and Go (TUG): The time taken is converted into a score (e.g., 1 to 5), with lower times indicating better performance.
Time frame: Baseline to 3 Month Follow Up
Change in Grip strength will be measured using the Jamar hand-held dynamometer which measures in pounds (up to 200 pounds). Higher recorded pounds equal a greater grip strength.
Time frame: Baseline to 3 Month Follow Up
Change in grip strength will be measured using the Jamar hand-held dynamometer which measures in pounds (up to 200 pounds). Higher recorded pounds equal a greater grip strength.
Time frame: Baseline to 3 Month Follow Up
Change in grip strength will be measured using the Jamar hand-held dynamometer which measures in pounds (up to 200 pounds). Higher recorded pounds equal a greater grip strength.
Time frame: Baseline to 3 Month Follow Up
Change in score for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30). This is a specialized questionnaire designed for cancer patients. It consists of 30 items that evaluate various dimensions of health and well-being, including: Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, Social Functioning, Global Health Status/Quality of Life, Symptom Scales. In scoring, 28 items are rated on a 4-point scale (1 = Not at all to 4 = Very much), and the last two items use a 7-point scale (1 = Very Poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale. For functional scales and the global health status/QoL scale, higher scores represent better functioning or quality of life. For symptom scales/items, higher scores indicate more severe symptoms.
Time frame: Baseline to 3 Month Follow Up
Change in score for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (30EORTC QLQ-C30). This is a specialized questionnaire designed for cancer patients. It consists of 30 items that evaluate various dimensions of health and well-being, including: Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, Social Functioning, Global Health Status/Quality of Life, Symptom Scales. In scoring, 28 items are rated on a 4-point scale (1 = Not at all to 4 = Very much), and the last two items use a 7-point scale (1 = Very Poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale. For functional scales and the global health status/QoL scale, higher scores represent better functioning or quality of life. For symptom scales/items, higher scores indicate more severe symptoms.
Time frame: Baseline to 3 Month Follow Up
Change in score for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core (30EORTC QLQ-C30). This is a specialized questionnaire designed for cancer patients. It consists of 30 items that evaluate various dimensions of health and well-being, including: Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, Social Functioning, Global Health Status/Quality of Life, Symptom Scales. In scoring, 28 items are rated on a 4-point scale (1 = Not at all to 4 = Very much), and the last two items use a 7-point scale (1 = Very Poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale. For functional scales and the global health status/QoL scale, higher scores represent better functioning or quality of life. For symptom scales/items, higher scores indicate more severe symptoms.
Time frame: Baseline to 3 Month Follow Up
Change in L-Dex Score. Lymphedema surveillance will be completed using the SOZOs Bioimpedance device and monitored with the L-Dex score provided by the device. The L-Dex score is derived from bioimpedance spectroscopy measurements, which assess the resistance and reactance of body tissues to an electrical current. This provides detailed information about fluid levels in the body. The L-Dex score typically ranges from -10 to +10, with values outside this range indicating potential fluid accumulation and risk of lymphedema.
Time frame: Baseline to 3 Month Follow Up
Change in L-Dex Score. Lymphedema surveillance will be completed using the SOZOs Bioimpedance device and monitored with the L-Dex score provided by the device. The L-Dex score is derived from bioimpedance spectroscopy measurements, which assess the resistance and reactance of body tissues to an electrical current. This provides detailed information about fluid levels in the body. The L-Dex score typically ranges from -10 to +10, with values outside this range indicating potential fluid accumulation and risk of lymphedema.
Time frame: Baseline to 3 Month Follow Up
Change in score of the L-Dex Score. Lymphedema surveillance will be completed using the SOZOs Bioimpedance device and monitored with the L-Dex score provided by the device. The L-Dex score is derived from bioimpedance spectroscopy measurements, which assess the resistance and reactance of body tissues to an electrical current. This provides detailed information about fluid levels in the body. The L-Dex score typically ranges from -10 to +10, with values outside this range indicating potential fluid accumulation and risk of lymphedema.
Contact information is provided by the study sponsor or research team.
McKinzey K Dierkes, DPT
CONTACT
Megan Clark, MD
CONTACT
West Virginia University
Other
Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
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