S.A.F.E. Study: Safety And Feasibility of Exercise for women with breast cancer

Queensland University of Technology0 sites60 target enrollmentApril 28, 2016

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Queensland University of Technology
Enrollment: 60
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 28, 2016

End Date

February 12, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Queensland University of Technology

Eligibility Criteria

Inclusion Criteria

•Women aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II\+; treated at one of the referring hospitals. The residence criterion will allow for the Accredited Exercise Physiologist (AEP) to travel to participants’ homes for intervention sessions. All participants must be undergoing or have completed treatment within the past 24 months, with the exception of hormone therapy. Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently not meet national physical activity level recommendations (\<150 minutes of weekly physical activity) PLUS meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one co\-morbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese \[body mass index\>25], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper\-body morbidity, neuropathy, fatigue, arthralgia). We will also accept self\-report of moderate to severe in intensity treatment sequelae, even in the absence of a clinical diagnosis. This self\-report criterion is necessary since treatment\-sequelae are not routinely screened, detected and recorded by follow\-up care (Cheville et al. 2012\). Our self\-report measures are ones that we have included our prospective cohort studies.

Exclusion Criteria

•Currently meeting the current exercise recommendations (i.e., sufficiently active); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) during the study period; unable to consent.