CLINICAL TRIAL

Engagement in Physical Activity for Breast Cancer

Stage I
Recruiting · 18 - 65 · Female · Chapel Hill, NC

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

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About the trial for Breast Cancer

Eligible Conditions
Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Engagement In Physical Activity is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Questionnaires
OTHER
Engagement in Physical Activity
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients between 18 and 65 years old. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
IRB approved, signed written informed consent
English speaking
21 to 64 years of age, female
Approval from their treating physician to engage in moderate-intensity physical activity
Patient-assessed ability to walk and engage in moderate physical activity
Willing and able to meet all study requirements.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post-Baseline and 12-months post-Baseline
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post-Baseline and 12-months post-Baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post-Baseline and 12-months post-Baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Engagement in Physical Activity will improve 1 primary outcome, 21 secondary outcomes, and 2 other outcomes in patients with Breast Cancer. Measurement will happen over the course of Baseline, 6-months post-Baseline.

Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form
BASELINE, 6-MONTHS POST-BASELINE
Will administer the PROMIS Cognitive Function-Short Form (8a). This Likert-type scale is from 1=very often to 5=never. Higher scores signify higher cognitive function. No subscales.
BASELINE, 6-MONTHS POST-BASELINE
Measure association of p16 with changes in functional status with the Karnofsky Performance Status
BASELINE, 6-MONTHS POST-BASELINE
Administer the Karnofsky Performance Status
BASELINE, 6-MONTHS POST-BASELINE
Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey
BASELINE, 6-MONTHS POST-BASELINE
Administer the Instrumental Activities of Daily Living Survey. This Likelrt-type scale is from 0=without help to 2=completely unable. Higher scores signify greater limitations. No subscale.
BASELINE, 6-MONTHS POST-BASELINE
Measure association of p16 with changes in functional status by the Medical Outcomes Survey.
BASELINE, 6-MONTHS POST-BASELINE
Administer the Medical Outcomes Survey. Likert-type scale from 0=without help to 2=completely unable. Higher score signifies more limitations. No subscale.
BASELINE, 6-MONTHS POST-BASELINE
Mean change in p16 between baseline to end of chemo, compared to previous studies
BASELINE, 6-MONTHS POST-BASELINE
Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention
BASELINE, 6-MONTHS POST-BASELINE
Measure association of p16 with number of Fall Questionnaire
BASELINE, 6-MONTHS POST-BASELINE
One question will inquire about falls within the past 6 months.
BASELINE, 6-MONTHS POST-BASELINE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get breast cancer a year in the United States?

The American Cancer Society estimates there will be around 219,600 new diagnoses of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), or 2.2% of women, will die of the disease in 2022.\n

Anonymous Patient Answer

What is the average age someone gets breast cancer?

The reported mean age of breast cancer onset is 63.4 years in the US population. Women from the two studies who report a personal history of breast cancer generally reported their age at onset was around the same age.

Anonymous Patient Answer

What are the chances of developing breast cancer?

There is significant differences in BC risk among people of different racial backgrounds. The association between race and breast cancer also varies by menopausal status.

Anonymous Patient Answer

What are the signs of breast cancer?

Symptoms in women with breast cancer may be due to both disease associated and systemic effects. Women, or their physicians may feel more suspicious about them if they experience more than one symptom from breast cancer, or report an question: Are we giving an adequate amount of information about the benefits of mammography to our female breast cancer patients? answer: The majority of women attending our community practices would be receptive to receiving regular and informative post-diagnosis information about mammography benefits and risks from their medical professional, irrespective of their age and other demographic or clinical factors.

Anonymous Patient Answer

Can breast cancer be cured?

Breast cancer, although curable when diagnosed early, is often diagnosed later. Although surgical treatment has increased survival, more than 90% of the patient population still have poor-prognosis disease, yet more than 30% of them are diagnosed with locally advanced or metastatic disease (>80% with distant-disease). The poor-prognosis tumor type, and its metastatic behavior as in the later-diagnosed-disease instances, make it even more likely for the disease to recur. However, if curability is achieved in the breast, the chance approaches 75% for relapse that can be cured at any subsequent location. Only 5% of cancers, all metastatic, are curable.

Anonymous Patient Answer

What are common treatments for breast cancer?

With an increasing trend of more aggressive local and systemic treatment, a shift of patients may have occurred. The new generation of patients, young women, who may not receive a mammogram at an earlier stage, may be misdiagnosed, and may come to the wrong conclusion of the efficacy of different treatment modalities.

Anonymous Patient Answer

What is breast cancer?

Breast cancer typically develops in a woman age between 35 and 50 years, and is usually not a rare disease. Early detection of the disease is a prerequisite for cure. Although the causes of breast cancer are complex, genetic and environmental factors work together to affect its progression.

Anonymous Patient Answer

What causes breast cancer?

Although the exact cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is unknown, this disorder is linked to certain predisposing factors and lifestyle behaviours. These factors include lifestyle choices, inherited, medical or autoimmune disease, family history, and environmental factors including diet and exposure to chemicals. Although these factors can all contribute to breast cancer, it is thought likely that risk is predominantly caused by genetic traits of cancer-prone families. The risk to the individual is very small, while breast cancer screening is currently the only method for detecting cancer at an early, curable stage.\n

Anonymous Patient Answer

Has engagement in physical activity proven to be more effective than a placebo?

This meta-analysis indicates that higher levels of PA were more effective than PL for achieving weight loss and maintenance of pre-intervention weight loss levels through 12 months after the intervention. Results from a recent clinical trial provides evidence to promote PA, but does not show a threshold dose for the effectiveness of PA.

Anonymous Patient Answer

Is engagement in physical activity typically used in combination with any other treatments?

In a recent study, findings demonstrate the use of physical activity as a primary therapeutic modality in the treatment of breast cancer. More comprehensive studies are required to evaluate the usefulness of this combination and to identify the active treatment and monitoring protocols necessary to maximize its effectiveness.

Anonymous Patient Answer

How quickly does breast cancer spread?

Rapid advances in modern medicine and surgical techniques will enable surgeons to achieve complete removal of the tumor. These improvements will hopefully decrease the morbidity and mortality of breast cancer, making timely detection of breast cancer important for survival.

Anonymous Patient Answer

What are the common side effects of engagement in physical activity?

The engagement in vigorous physical activity and moderate intensities resulted in the same benefits and side effects for the majority of the women surveyed. However, the engagement in low intensity activity and moderate intensity activity increased the incidence of body weight gain, low grade diarrhea, and fatigue in more than 10% of the participating women. Therefore, physical activity guidelines for healthy women should include recommendations for the intensity, duration and number of activity sessions, and the possible need for supplementation of vitamins and minerals.

Anonymous Patient Answer
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