Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial

Journal article


Jennifer Brunet, Meagan Barrett-Bernstein, Kendra Zadravec, Monica Taljaard, Nathalie Levasseur, Amirrtha Srikanthan, Kelcey Bland, Barbara Collins, Julia W. Y. Kam, Todd C. Handy, Sherri Hayden, Christine Simmons, Andra M. Smith, Naznin Virji-Babul and Kristin L. Campbell. (2020). Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. BMC Cancer. 20(1), pp. 1-14. https://doi.org/10.1186/s12885-020-07196-3
AuthorsJennifer Brunet, Meagan Barrett-Bernstein, Kendra Zadravec, Monica Taljaard, Nathalie Levasseur, Amirrtha Srikanthan, Kelcey Bland, Barbara Collins, Julia W. Y. Kam, Todd C. Handy, Sherri Hayden, Christine Simmons, Andra M. Smith, Naznin Virji-Babul and Kristin L. Campbell
Abstract

Background
Up to 75% of women diagnosed with breast cancer report chemotherapy-related cognitive changes (CRCC) during treatment, including decreased memory, attention, and processing speed. Though CRCC negatively impacts everyday functioning and reduces overall quality of life in women diagnosed with breast cancer, effective interventions to prevent and/or manage CRCC are elusive. Consequently, women seldom receive advice on how to prevent or manage CRCC. Aerobic exercise is associated with improved cognitive functioning in healthy older adults and adults with cognitive impairments. Accordingly, it holds promise as an intervention to prevent and/or manage CRCC. However, evidence from randomized controlled trials (RCTs) supporting a beneficial effect of aerobic exercise on CRCC is limited. The primary aim of the ACTIVATE trial is to evaluate the impact of supervised aerobic exercise on CRCC in women receiving chemotherapy for breast cancer.

Methods
The ACTIVATE trial is a two-arm, two-centre RCT. Women diagnosed with stage I-III breast cancer and awaiting neo-adjuvant or adjuvant chemotherapy are recruited from hospitals in Ottawa (Ontario) and Vancouver (British Columbia), Canada. Recruits are randomized to the intervention group (aerobic exercise during chemotherapy) or the wait-list control group (usual care during chemotherapy and aerobic exercise post-chemotherapy). The primary outcome is cognitive functioning as measured by a composite cognitive summary score (COGSUM) of several neuropsychological tests. Secondary outcomes are self-reported cognitive functioning, quality of life, and brain structure and functioning (measured by magnetic resonance imaging (MRI)/functional MRI and electroencephalography). Assessments take place pre-chemotherapy (pre-intervention), mid-way through chemotherapy (mid-intervention/mid-wait period), end of chemotherapy (post-intervention/post-wait period; primary endpoint), 16-weeks post-chemotherapy, and at 1-year post-baseline.

Discussion
Aerobic exercise is a promising intervention for preventing and/or managing CRCC and enhancing quality of life among women diagnosed with breast cancer. The ACTIVATE trial tests several novel hypotheses, including that aerobic exercise can prevent and/or mitigate CRCC and that this effect is mediated by the timing of intervention delivery (i.e., during versus post-chemotherapy). Findings may support prescribing exercise during (or post-) chemotherapy for breast cancer and elucidate the potential role of aerobic exercise as a management strategy for CRCC in women with early-stage breast cancer.

Keywordsrandomized controlled trial; chemotherapy-related cognitive changes; chemo-brain; aerobic exercise; breast neoplasm
Year2020
JournalBMC Cancer
Journal citation20 (1), pp. 1-14
PublisherBiomed Central Ltd
ISSN1471-2407
Digital Object Identifier (DOI)https://doi.org/10.1186/s12885-020-07196-3
Scopus EID2-s2.0-85089113825
Open accessPublished as ‘gold’ (paid) open access
Publisher's version
License
File Access Level
Open
Publication process dates
Deposited30 Apr 2021
Permalink -

https://acuresearchbank.acu.edu.au/item/8vyy9/study-protocol-of-the-aerobic-exercise-and-cognitive-functioning-in-women-with-breast-cancer-activate-trial-a-two-arm-two-centre-randomized-controlled-trial

Download files


Publisher's version
OA_Brunet_2020_Study_protocol_of_the_Aerobic_exercise.pdf
License: CC BY 4.0
File access level: Open

  • 64
    total views
  • 28
    total downloads
  • 0
    views this month
  • 0
    downloads this month
These values are for the period from 19th October 2020, when this repository was created.

Export as

Related outputs

"I want to get myself as fit as I can and not die just yet" - Perceptions of exercise in people with advanced cancer and cachexia : A qualitative study
Bland, Kelcey A., Krishnasamy, Meinir, Parr, Evelyn B., Mulder, Stella, Martin, Peter, van Loon, Luc, Cormie, Prue, Michael, Natasha and Zopf, Eva M.. (2022). "I want to get myself as fit as I can and not die just yet" - Perceptions of exercise in people with advanced cancer and cachexia : A qualitative study. BMC Palliative Care. 21(1), p. Article 75. https://doi.org/10.1186/s12904-022-00948-x
Exercise-based multimodal programming : A treatment gap for older adults with advanced cancer [Commentary]
Small, Stephanie, Bland, Kelcey, Rickard, Julia and Kirkham, Amy. (2022). Exercise-based multimodal programming : A treatment gap for older adults with advanced cancer [Commentary] Oxford University Press. https://doi.org/10.1093/oncolo/oyab009
Taking advantage of the teachable moment at initial diagnosis of prostate cancer—Results of a pilot randomized controlled trial of supervised exercise training
Schulz, Gerald B., Locke, Jennifer A., Campbell, Kristin L., Bland, Kelcey A., Van Patten, Cheri L., Black, Peter C., Goldenberg, S. Larry and Flannigan, Ryan. (2022). Taking advantage of the teachable moment at initial diagnosis of prostate cancer—Results of a pilot randomized controlled trial of supervised exercise training. Cancer Nursing. 45(3), pp. E680-E688. https://doi.org/10.1097/NCC.0000000000001013
Attention to principles of exercise training : An updated systematic review of randomized controlled trials in cancers other than breast and prostate
Bland, Kelcey A., Neil-Sztramko, Sarah E., Zadravec, Kendra, Medysky, Mary E., Kong, Jeffrey, Winters-Stone, Kerri M. and Campbell, Kristin L.. (2021). Attention to principles of exercise training : An updated systematic review of randomized controlled trials in cancers other than breast and prostate. BMC Cancer. 21(1), p. Article 1179. https://doi.org/10.1186/s12885-021-08701-y
Quality of life and symptom burden improve in patients attending a multidisciplinary clinical service for cancer cachexia : A retrospective observational review
Bland, Kelcey A., Harrison, Meg, Harrison, Meg, Zopf, Eva M., Sousa, Mariana S., Currow, David C., Ely, Matthew, Agar, Meera, Butcher, Belinda E., Vaughan, Vanessa, Dowd, Anna and Martin, Peter. (2021). Quality of life and symptom burden improve in patients attending a multidisciplinary clinical service for cancer cachexia : A retrospective observational review. Journal of Pain and Symptom Management. 62(3), pp. e164-e176. https://doi.org/10.1016/j.jpainsymman.2021.02.034
Prognostic markers of overall survival in cancer patients attending a cachexia support service : An evaluation of clinically assessed physical function, malnutrition and inflammatory status
Bland, Kelcey A., Zopf, Eva M., Harrison, Meg, Ely, Matthew, Cormie, Prue, Liu, E., Dowd, Anna and Martin, Peter. (2020). Prognostic markers of overall survival in cancer patients attending a cachexia support service : An evaluation of clinically assessed physical function, malnutrition and inflammatory status. Nutrition and Cancer. 73(8), pp. 1400-1410. https://doi.org/10.1080/01635581.2020.1800765
Impact of exercise on chemotherapy tolerance and survival in early-stage breast cancer : A nonrandomized controlled trial
Kirkham, Amy A., Gelmon, Karen A., Van Patten, Cheri L., Bland, Kelcey A., Wollmann, Holly, McKenzie, Donald C., Landry, Taryne and Campbell, Kristin L.. (2020). Impact of exercise on chemotherapy tolerance and survival in early-stage breast cancer : A nonrandomized controlled trial. Journal of the National Comprehensive Cancer Network. 18(12), pp. 1670-1677. https://doi.org/10.6004/jnccn.2020.7603
PUB0201081895
Kirkham, Amy A., Virani, Sean A., Bland, Kelcey A., McKenzie, Donald C., Gelmon, Karen A., Warburton, Darren E. R. and Campbell, Kristin L.. (2020). PUB0201081895. Breast Cancer Research and Treatment. 184, pp. 75-85. https://doi.org/10.1007/s10549-020-05824-x
The effect of exercise on cancer-related cognitive impairment and applications for physical therapy : Systematic review of randomized controlled trials
Campbell, Kristin L., Zadravec, Kendra, Bland, Kelcey A., Chesley, Elizabeth, Wolf, Florian and Janelsins, Michelle C.. (2020). The effect of exercise on cancer-related cognitive impairment and applications for physical therapy : Systematic review of randomized controlled trials. Physical Therapy. 100(3), pp. 523-542. https://doi.org/10.1093/ptj/pzz090
Updated systematic review of exercise studies in breast cancer survivors : Attention to the principles of exercise training
Neil-Sztramko, Sarah E., Winters-Stone, Kerri M., Bland, Kelcey A. and Campbell, Kristin L.. (2019). Updated systematic review of exercise studies in breast cancer survivors : Attention to the principles of exercise training. British Journal of Sports Medicine. 53(8), pp. 504-512. https://doi.org/10.1136/bjsports-2017-098389
Impact of exercise on chemotherapy completion rate: A systematic review of the evidence and recommendations for future exercise oncology research
Bland, Kelcey, Zadravec, Kendra, Landry, Taryne, Weller, Sarah, Meyers, Logan and Campbell, Kristin L.. (2019). Impact of exercise on chemotherapy completion rate: A systematic review of the evidence and recommendations for future exercise oncology research. Critical Reviews in Oncology Hematology. 136, pp. 79 - 85. https://doi.org/10.1016/j.critrevonc.2019.02.005
Clinically relevant physical benefits of exercise interventions in breast cancer survivors
Kirkham, Amy A., Bland, Kelcey A., Sayyari, Sarah, Campbell, Kristin L. and Davis, Margot K.. (2016). Clinically relevant physical benefits of exercise interventions in breast cancer survivors. Current Oncology Reports. 19(12), p. Article: 12. https://doi.org/10.1007/s11912-015-0496-3