Skip to main content

Physical Activity Program for the Improvement of Quality of Life in Female Stage I-IIIA Breast Cancer Survivors

Trial Status: Complete

This phase II trial studies the effects of aerobic exercise training on cognitive function (memory and attention), lifestyle behaviors, and quality of life in female stage I-IIIA breast cancer survivors. Many women that have been treated for breast cancer experience declines in memory that go beyond those of normal aging. The purpose of this study is to evaluate a physical activity program to help develop additional programs aimed at improving the quality of life in women with breast cancer.

Inclusion Criteria

  • Post-menopausal at time of breast cancer diagnosis. We are targeting post-menopausal women only because: * 93% of breast cancer diagnoses are in women 50 years of age and older; and * Evidence suggests cancer treatment-induced amenorrhea may be independently associated with creatinine clearance (CRCl), which, in our small sample, could interfere with our ability to successfully test our specific aims. In an effort to reduce any confounding effects this factor may have on our analyses, we have, under the guidance of primary investigator and medical consultant (Co-I Reed), decided to exclude women who were pre- or peri-menopausal at diagnosis. Finally, due to the interaction between aging and cancer, post-menopausal survivors may be at greatest risk of cognitive decline after breast cancer diagnosis
  • First, primary diagnosis of stage I-IIIa breast cancer
  • Completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-24 months prior to study start. No exclusion criteria relative to type(s) of adjuvant therapy received will be applied in this study. Women currently prescribed adjuvant endocrine therapy (e.g., aromatase inhibitor, estrogen receptor downregulator, selective estrogen receptor modulator) will be eligible to participate * Although, CRCI has been reported in cancer survivors up to 20 years after the end of treatment, we have chosen to focus our study on women 3-24 months post-treatment. Our previous work demonstrated significant effects of physical activity on cognitive function in women ~8 years from their breast cancer diagnosis. However, recent clinical exercise trials have observed significant effects on cognitive functions in women up to two years after their diagnosis. Additionally, previous studies suggest the first year post-treatment may represent a “teachable moment” relative to lifestyle behavior adoption and cancer rehabilitation. As such, we will focus recruitment on the first two years post-treatment and will actively monitor recruitment. * Our initial efforts to recruit subjects suggests the narrow inclusion criterion originally approved by the scientific review committee (SRC) may significantly slow our progress toward achieving our targeted enrollment. As such, we plan to expand this criterion to 24 months post-treatment
  • We have chosen not to exclude women who did not receive chemotherapy for their cancer because deficits in cognition have been observed in women before receipt of adjuvant chemotherapy and in women who did not receive chemotherapy for their breast cancer; We agree that receipt of chemotherapy may exacerbate the cumulative effects of a cancer diagnosis on cognitive function; however, the currently available scientific evidence in this area does not warrant excluding women who have not received chemotherapy for their breast cancer
  • Self-report an average of < 60 minutes of moderate to vigorous physical activity per week for the previous 6 months
  • Available to attend exercise sessions 3 times weekly for 12 weeks
  • No scheduled travel for greater than 7 consecutive days during the 12-week intervention period
  • Agree to be randomized to an exercise group or usual care group
  • Fitbit specific criteria: * Compatible mobile device, laptop computer, or desktop computer * Willingness to continuously wear the Fitbit device during waking hours for the duration of the study period. Individuals not willing to wear the Fitbit during sleep will be eligible to participate * Willingness and ability to charge and synchronize the Fitbit device at home every 3-4 days
  • English reading and speaking
  • Receive physicians clearance to participate in an exercise program
  • Provide written informed consent to participate in the study

Exclusion Criteria

  • Female who was pre- or peri-menopausal at the time she was diagnosed with breast cancer
  • Stage 0 breast cancer diagnosis or metastatic disease
  • Currently receiving chemotherapy or radiation therapy for any cancer or greater than 24-months post-treatment
  • Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period
  • Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
  • Self-report an average of >= 60 minutes of moderate to vigorous physical activity per week for the previous 6 months
  • Is not cleared to participate in exercise by a physician. Complications warranting exclusion from the present study are listed on the physicians clearance and include: * History of major multiple myocardial infarctions (MI) * Recent electrocardiogram (ECG) changes or recent MI * Resting or unstable angina * Significant multivessel coronary occlusion (>= 70%) on angiography * Uncontrolled and/or serious arrhythmias * 3rd degree heart block * Acute congestive heart failure or ejection fraction < 30%
  • Not available to attend 3 times weekly exercise sessions for 12 weeks
  • Out of town travel scheduled for > 1 week during the 12-week intervention
  • Unwilling to complete baseline physical, neural, neurocognitive, and patient-reported assessments (submaximal treadmill test, electroencephalography [EEG], cognitive tasks, questionnaires)
  • Unwilling to be randomized to the exercise or control group
  • Unwilling to continuously wear and regularly sync/charge the Fitbit device during the study period
  • Unable to read and speak in English
  • Unwilling to provide written informed consent to participate
  • Cognitive impairment (Telephone Interview of Cognitive status [13-item modified version; TICS-M] score < 21) prior to baseline assessment
  • History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
  • WITHDRAWAL CRITERIA: Diagnosed with breast cancer recurrence or second primary cancer (excluding non-invasive skin cancers)
  • WITHDRAWAL CRITERIA: Unplanned surgery (including breast surgery)
  • WITHDRAWAL CRITERIA: Acute changes in neurological status after enrollment (e.g. traumatic brain injury, stroke)
  • WITHDRAWAL CRITERIA: Intervention participants who miss 3 or more consecutive exercise sessions without notifying the research team and who the research team is unable to contact
  • WITHDRAWAL CRITERIA: Subjects withdrawing consent at any time during the study will be withdrawn from the study

Nebraska

Omaha
Nebraska Methodist Hospital
Status: COMPLETED
Contact: Kathryn C. Simone
University of Nebraska Medical Center
Status: COMPLETED
Contact: Diane Ehlers
Phone: 402-552-7945

PRIMARY OBJECTIVES:

I. Examine the preliminary effects of a 12-week walking program, compared with usual care, on executive function and working memory in post-menopausal breast cancer survivors who are 3-24 months post-treatment (N = 40).

II. Generate preliminary data on the clinical, neurobiological, physiological, and psychosocial correlates of the effects of exercise on executive function and working memory in post-menopausal breast cancer survivors who are 3-24 months post-treatment (N = 40).

III. Test the feasibility and acceptability of the protocol in post-menopausal breast cancer survivors who are 3-24 months post-treatment (N = 40).

OUTLINE:

Patients complete a treadmill-based exercise test during Appointment 1 and wear an Actigraph for 7 days. Approximately 7-10 days after Appointment 1, patients undergo neurocognitive testing over 1 hour and cognitive electrophysiology over 1 hour (Appointment 2). Patients also receive a FitBit. Patients may choose to undergo a brain magnetic resonance imaging scan over 1 hour (Appointment 3). Patients are then randomized to 1 of 2 arms.

ARM I: Patients participate in supervised moderate-to-vigorous walking sessions three times a week (TIW) over 1 hour each and on their own for at least 1-2 days weekly over approximately 30 minutes each over 12 weeks. Patients also receive weekly telecoaching sessions over 12 weeks and wear a FitBit to monitor their physical activity and sleep, and receive a 3-month fitness center membership when local fitness centers are reopened.

ARM II: Patients may choose to participate in 2 personalized exercise sessions with a trained exercise specialist over 12 weeks. Patients also wear a FitBit to monitor their physical activity and sleep, and receive a 3-month fitness center membership when local fitness centers are reopened.

After completion of study, patients are followed up periodically.

Trial Phase Phase II

Trial Type Supportive care

Lead Organization
University of Nebraska Medical Center

Principal Investigator
Diane Ehlers

  • Primary ID 091-19
  • Secondary IDs NCI-2019-07496
  • Clinicaltrials.gov ID NCT03980626