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Activity & Cognition After Treatment for Breast Cancer (ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592070
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign

Brief Summary:
This study addresses an important public health concern; impoverished cognitive function associated with treatment of breast cancer. Due to increased awareness of breast cancer combined with advances in medical care, there are over 2.8 million women living with a history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. However, most of the literature is cross-sectional and it is unclear whether acute (single) bouts of physical activity affect cognition and, if they do, how long this effect lasts. This study will be the first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators will determine the effects of a 30-minute moderate intensity aerobic exercise session (treadmill walking) on immediate and one hour follow up changes in measures of processing speed, memory, and executive function. Additionally, accelerometer cut-points for physical activity intensities in breast cancer survivors will be assessed. Finally, the investigators will examine the association of cardiorespiratory fitness and physical activity with changes in cognitive function. Findings from this study will allow researchers to determine whether any acute effects of exercise on cognition are retained over time and therefore have real meaning in the context of one's daily life.

Condition or disease Intervention/treatment Phase
Breast Cancer Mild Cognitive Impairment Physical Activity Behavioral: Walking Not Applicable

Detailed Description:

This study addresses an important public health concern: impoverished cognitive function associated with treatment of breast cancer. Due to increased awareness of breast cancer combined with advances in medical care, the 5-year survival rate has climbed to 89.2% with over 2.8 million women living with a history of breast cancer in the U.S. alone.

Unfortunately, the treatment of breast cancer is not without its consequences. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. While past studies have identified memory and executive function as valuable, important determinants of long-term survival and quality of life in survivors of different types of cancer, it is unclear if standard care methods alone prove successful in attenuating declines in these variables. Previous research in breast cancer populations has found that executive function difficulties, namely in working memory, cognitive flexibility, and processing speed, as well as fatigue, are the most commonly described deficits. Furthermore, evidence suggests impairments in cognitive functioning may persist in up to 35% of breast cancer survivors years after treatment ends.

A behavioral and lifestyle modality known to improve physical and mental health status and protect against health declines is physical activity. Not only is physical activity known to protect against a host of diseases, but it also has been shown to provide many health benefits to breast cancer survivors. While the extant literature suggests that physical activity can lead to improvements in varying cognitive domains in breast cancer survivors, another study concluded that only 32% of these survivors meet the recommended guidelines for physical activity. Additionally, while benefits from physical activity for breast cancer survivors are well known, there is currently no scientifically recognized physical activity training program aimed at improving cognitive function in this cohort.

As such, a review chapter examining cognitive impairment in breast cancer survivors suggests more comprehensive studies examining the relationship between objective measures of physical activity, cardiorespiratory fitness, and cognitive performance are warranted to gain a better understanding of the potentially protective effects of fitness and physical activity on cognitive functioning in breast cancer survivors for better survival along the cancer continuum. In addition, other research has shown that subjective memory impairment, fatigue, and anxiety plague breast cancer survivors and suggests that breast cancer survivors may suffer from poorer quality of life as a result. Furthermore, it has been shown that breast cancer survivors have longer reaction time to working memory tasks compared to healthy, age-matched controls, and those survivors with higher levels of physical activity had shorter reaction times for more difficult tasks. A recent study also measured levels of objective physical activity and found those with higher levels displayed more positive measures of global cognition.

Despite this evidence, it is unknown if acute (single) bouts of exercise can provide benefits in varying cognitive domains. Previous research has shown that acute bouts of aerobic physical activity, of both light and moderate intensity, decrease state anxiety in breast cancer survivors. However, it is not known if these benefits extend to cognitive functioning. Furthermore, most of these results are founded in cross-sectional research and it is unclear whether acute bouts of physical activity improve cognition and, if they do, how long this effect lasts. This has implications for real world contexts in that, if benefits are present, breast cancer survivors can find relief in cognitive symptoms quickly by simply engaging in a bout of physical activity. This study will be the first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic exercise on cognitive functioning in breast cancer survivors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Activity & Cognition After Treatment (ACT) for Breast Cancer
Study Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 30 minute treadmill walking
All participants will walk on the treadmill for 30 minutes and perform a battery of cognitive tasks immediately prior, immediately after, and one hour after completion of the 30 minute walking period.
Behavioral: Walking
Participants will walk on the treadmill for 30 minutes at a moderate intensity.




Primary Outcome Measures :
  1. Change from baseline in cognitive function in breast cancer survivors immediately and one hour after an acute bout of exercise as assessed by a battery of cognitive functioning measures. [ Time Frame: 1 year ]
    Participants will complete cognitive tasks, then exercise on a treadmill for 30 minutes before completing the same cognitive tasks again. Participants will then rest before completing the cognitive tasks one more time one hour after the end of the exercise period.


Secondary Outcome Measures :
  1. Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by physical activity and fitness levels. [ Time Frame: 1 year ]
    The investigators wish to explore if participants with higher levels of fitness and higher levels of physical activity exhibit different levels of cognitive functioning compared to their less fit and less active peers.

  2. Physical activity guidelines in breast cancer survivors as assessed by graded exercise test. [ Time Frame: 60 minutes ]
    Participants will wear an accelerometer while performing a graded maximal exercise test. The output of the accelerometer will be compared to that of the exercise test to determine what levels of activity line up with varying metabolic equivalents. This will help us determine physical activity guidelines for breast cancer survivors.

  3. Change from baseline in anxiety levels after one bout of exercise as assessed by HADS questionnaire. [ Time Frame: 30 minutes ]
    Participants will complete a short anxiety questionnaire before and after a 30 minute bout of aerobic exercise. The investigators will then compare the pre- and post- values to examine if any changes are present.

  4. Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by psychosocial questionnaires. [ Time Frame: 1 year ]
    Participants will take home a short battery of questionnaires designed to assess psychosocial outcomes. They will bring it back one week later. The investigators will then explore if participants with higher levels of any of these variables exhibit higher levels of cognition and/or fitness compared to peers with lower levels of psychological constructs.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women between 30 and 60 years of age
  • diagnosis of breast cancer
  • no longer undergoing treatment
  • fluent in English
  • no history of dementia or organic brain syndrome
  • not currently pregnant
  • able to walk unassisted
  • no health reasons that would prevent ability to exercise
  • not currently enrolled in another exercise research study
  • reported trouble with memory/concentration
  • physician's consent

Exclusion Criteria:

  • male
  • no diagnosis of breast cancer
  • outside of 30-60 years of age
  • currently undergoing treatment for breast cancer
  • inability to communicate in English
  • history of dementia or organic brain syndrome
  • pregnant
  • unable to walk unassisted
  • other health reasons that may prevent ability to exercise
  • enrolled in another exercise research study
  • no reported trouble with memory or concentration
  • non-consent of physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592070


Locations
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United States, Illinois
Freer Hall, University of Illinois
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Edward McAuley, PhD University of Illinois at Urbana-Champaign
Additional Information:
Publications:
Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) Research Data (2004-2010), National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2014, based on the November 2013 submission.
Baumann, F. T., Drosselmeyer, N., Leskaroski, A., Knicker, A., Krakowski-Roosen, H., Zopf, E. M., & Bloch, W. (2011). 12-week resistance training with breast cancer patients during chemotherapy: Effects on cognitive abilities. Breast Care, 6(2), 142-143.
Mackenzie, M., Zuniga, K., & McAuley, E. (in press). Cognitive impairment in breast cancer survivors: The protective role of physical activity, cardiorespiratory fitness, and exercise training. Exercise-Cognition Interaction: Neuroscience Perspectives.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edward McAuley, Shahid and Ann Carlson Khan Professor in Applied Health Sciences, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02592070    
Other Study ID Numbers: UIUC_IRB_15575
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders