Table 1 Participant eligibility criteria and assessment methods in the BETA Trial, Alberta, Canada
From: Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA)
Reason for criterion | Assessment methods | Timing of assessment |
|---|---|---|
Appropriate target group for breast cancer risk reduction | ||
Female | Screen Test 1 database | Before contacting participant/immediately upon contact |
Age 50–74 years at baseline | Screen Test database or PEQ2 | Before contacting participant |
Postmenopausal | PEQ | After participant indicates interest |
No previous breast cancer diagnosis | PEQ | After participant indicates interest |
Fit to undertake exercise program | ||
No major co-morbidities | Screening questionnaires and blood tests | After participant indicates interest |
No previous invasive cancer | PEQ | After participant indicates interest |
Passes the self-completed Physical Activity Readiness Questionnaire | PEQ | After participant indicates interest |
Obtains physician approval to participate | PARmed-X3; approval to do 60 minutes of aerobic exercise (“unrestricted physical activity – start slowly and build up gradually”) five times/week for 12 months | After Information Session |
Acceptably healthy heart and lung function during fitness test | Sub-maximal treadmill test | After blood sample and obtaining physician approval |
Risk profile amenable to change with exercise intervention | ||
Body mass index 22.0-40.0 | PEQ (screening) and objective measurement of height and weight | After participant indicates interest (PEQ) and after exercise tester approval (height and weight) |
Moderately sedentary lifestyle (no more than 3 days/week of moderate-intensity recreational activity lasting a maximum of <30 minutes/session). Or, no more than 120 minutes of moderate-intensity recreational activity/week. | PEQ (screening) and PYTPAQ4 (comprehensive) | After participant indicates interest (PEQ) and at Information Session (PYTPAQ) |
Estimated VO2max ≤ 34.5 mL/kg/min. If VO2max was between 34.6 and 37.0 mL/kg/min, accelerometer count <10,000 steps/day over seven days. | Sub-maximal treadmill test; seven-day accelerometry (Actigraph GT3Xplus®) if VO2max 34.6-37.0 mL/kg/min | After physician approval |
No other outside factors to influence estrogen metabolism | ||
Not currently, previously (<6 months) or planning to take drugs related to estrogen metabolism or breast tissue growth | PEQ | After participant indicates interest |
Not a current smoker, or excessive drinker | PEQ | After participant indicates interest |
Smoker = needs to have quit for at least 6 months | ||
Drinking maximum = no more than 14 drinks/week | ||
Not currently or planning to undertake a weight control/loss program or taking weight loss medications | PEQ | After participant indicates interest |
Logistics | ||
Lives in Calgary or Edmonton | Screen Test database and PEQ | Before contacting participant and after participant indicates interest |
English-speaking | Initial contact with participant and PEQ | After participant indicates interest (telephone recruiters will ascertain) |
Not planning to be out of Calgary/Edmonton area more than 4 consecutive weeks during the subsequent 18 months or more than 8 weeks during the entire year. | PEQ | After participant indicates interest |