Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial

Journal article

Brigid M Lynch, Nga Nguyen, Marina M. Reeves, Melissa Moore, Dori E Rosenberg, Michael Wheeler, Terry Boyle, Jeff K. Vallance, Christine M Friedenreich and Dallas English. (2018). Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial. Contemporary Clinical Trials. 64, pp. 112-117. https://doi.org/10.1016/j.cct.2017.10.015
AuthorsBrigid M Lynch, Nga Nguyen, Marina M. Reeves, Melissa Moore, Dori E Rosenberg, Michael Wheeler, Terry Boyle, Jeff K. Vallance, Christine M Friedenreich and Dallas English
Abstract

Background
Physical activity is positively associated with survival and quality of life among breast cancer survivors. Despite these benefits, the majority of breast cancer survivors are insufficiently active. The potential health benefits of reducing sedentary behaviour (sitting time) in this population have not been extensively investigated. The ACTIVATE Trial will evaluate the efficacy of an intervention that combines wearable technology (the Garmin Vivofit2®) with traditional behavioural change approaches to increase physical activity and reduce sedentary behaviour performed by breast cancer survivors.

Methods/design
This randomised controlled trial includes inactive, postmenopausal women diagnosed with stage I-III breast cancer who have completed their primary treatment. Participants are randomly assigned to the primary intervention group (Garmin Vivofit2®; behavioural feedback and goal setting session; and, five telephone-delivered health coaching sessions) or to the wait-list control group. The primary intervention is delivered over a 12-week period. The second 12-week period comprises a maintenance phase for the primary intervention group, and an abridged intervention (Garmin Vivofit2® only) for the wait-list control group. Moderate- to vigorous-intensity physical activity (MVPA) and sedentary behaviour are assessed by accelerometry at baseline (T1), end of intervention (T2), and end of maintenance phase (T3).

Discussion
The ACTIVATE Trial is one of the first studies to incorporate wearable technology into an intervention for cancer survivors. If the use of wearable technology (in combination with behaviour change strategies, or alone) proves efficacious, it may become an inexpensive and sustainable addition to the health promotion strategies available to health care providers in the cancer survivorship context.

Keywordswearable technology; activity trackers; physical activity; sedentary behaviour; breast cancer survivors
Year2018
JournalContemporary Clinical Trials
Journal citation64, pp. 112-117
PublisherElsevier Inc.
ISSN1551-7144
Digital Object Identifier (DOI)https://doi.org/10.1016/j.cct.2017.10.015
Scopus EID2-s2.0-85032831498
Publisher's version
File Access Level
Controlled
Publication process dates
Deposited13 May 2021
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