The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AHS Cancer Control Alberta
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in sedentary time, light intensity physical activity time and moderate-vigorous intensity physical activity time (hours/day)
Study Overview
Brief Summary
The Breast Cancer & Physical Activity Level (BC-PAL) pilot study is a randomized controlled pilot trial aimed at evaluating whether total physical activity levels, health-related fitness and patient reported outcomes are improved by promoting different intensities of physical activity participation within a home-based setting, and whether these improvements are maintained over the long-term, in inactive breast cancer survivors.
Detailed Description
Detailed Description
Rationale and Significance:
Breast cancer is the most common cancer among Canadian women. Physical activity has emerged as a potential lifestyle factor for improving rehabilitation and survival after breast cancer. The American Cancer Society recommends that cancer survivors engage in at least 150 minutes of moderate-vigorous intensity physical activity per week. However, only ≈ 15% of breast cancer survivors reported meeting these physical activity guidelines. Therefore, interventions that promote physical activity behavior change in an unsupervised/home-based setting are needed to provide the necessary tools and support for breast cancer survivors. No study to date has assessed the effects of a lighter intensity physical activity intervention, compared to no additional physical activity prescription (control) or a higher intensity physical activity intervention (comparable to current exercise guidelines), in inactive breast cancer survivors, in addition to the longer-term maintenance effects of these interventions.
Study Aims:
Aim 1: To evaluate the effects of prescribing an additional 300 minutes/week of lighter intensity physical activity (LIPA) or 150 minutes/week of higher intensity physical activity (HIPA) versus no physical activity intervention (control) on total physical activity and sedentary time in inactive breast cancer survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically-confirmed Stage I-III breast cancer diagnosis
- •Completion of adjuvant treatment (chemotherapy, radiation therapy and surgery) except for hormone therapy
- •Females ≥18 years of age
- •Currently living in the Calgary area and able to meet with study staff at the Holy Cross Center on at least six occasions (twice as baseline, 12- and 24-weeks)
- •Currently inactive (accumulating ≤ 60 minutes of moderate-vigorous intensity physical activity/week and ≤ 10,000 steps/day)
- •Ability to undertake a physical activity program [assessed by an Exercise Physiologist with the Physical Activity Readiness Questionnaire (PAR-Q+)].
Exclusion Criteria
- •Deemed too active (accumulating on average ≥ 60 minutes of moderate-vigorous intensity physical activity/week and ≥ 10,000 steps/day)
- •Being away from Calgary or not able to attend testing sessions/be contacted by study staff for > 4 consecutive weeks during the intervention period.
Arms & Interventions
control
Receive no physical activity intervention (maintain baseline physical activity participation)
Lighter intensity physical activity
Receive an intervention of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve for 12 weeks.
Intervention: Lighter intensity physical activity intervention (Behavioral)
Higher intensity physical activity
Receive an intervention of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve for 12 weeks.
Intervention: Higher intensity physical activity intervention (Behavioral)
Outcomes
Primary Outcomes
Change in sedentary time, light intensity physical activity time and moderate-vigorous intensity physical activity time (hours/day)
Time Frame: Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)
Measured with accelerometry over seven days
Secondary Outcomes
- Change in body weight (kg)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
- Change in height (cm)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
- Change in body composition (fat and lean mass in kg)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
- Change in waist and hip circumference (cm)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
- Change in cardiorespiratory fitness (VO2max)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
- Change in body mass index (BMI in kg/m2)(Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period))
Investigators
Christine Friedenreich
Principal Investigator
AHS Cancer Control Alberta