Developing a Healthy Lifestyle in Breast Cancer Survivors

Study Overview
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Brief Summary
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At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8 hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month conditions: lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk); lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day], low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.

Official Title
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Developing a Healthy Lifestyle in Breast Cancer Survivors

Conditions
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Breast Cancer, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Common intervention components for Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 65 yrs BMI between 25 and 45 kg/m2 history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years completion of initial therapies engage in > 8 hours a day of SB engage in < 100 min/wk MVPA. Exclusion Criteria: report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)25 (The Health Screening Questionnaire will also be used to identify individuals with joint problems, prescription medication usage, or other medical conditions that could limit exercise, and these individuals will be required to obtain written physician consent to participate - the two questionnaires are found in questions 4-11 in the phone screen in Appendix B) report being unable to walk for 2 blocks (1/4 mile) without stopping report major psychiatric diseases or organic brain syndromes report a serious medical condition in which weight loss is contraindicated are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months have had bariatric surgery or are planning to have bariatric surgery in the next 6 months are participating in a program to increase physical activity and/or decrease sedentary time intend to move outside of the metropolitan area within the time frame of the investigation are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition; do not own a smartphone that will run the app required for the Polar® Loop device; are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or have a metal allergy or are not able to wear anything on an upper arm (which would prevent the ability of participant to wear the SenseWear® armband from BodyMedia® used in the proposed study).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle<br>Participants will be educated on the relationship between MVPA and improved health outcomes, including weight management, and cancer survivorship. The goal will be to increase MVPA to > 40 min/day 5 times/wk As participants will be overweight/obese, inactive, and coming into the program with different levels of baseline fitness and time since last cancer treatment, participants will shape their MVPA to meet the targeted goals. Initially, participants will be encouraged to complete MVPA > 10 min/day 5 times/wk, and then progressively increase MVPA by 5 min/day every week until reaching the intervention goal (week 7 of the 12 week intervention). Participants will be encouraged to do brisk walking and be allowed to accumulate time spent being physically active by engaging in multiple short bouts (i.e., > 10 min in length). Any MVPA in bouts of > 10 min in length will be counted towards the MVPA goal. Participants will self-monitor their MVPA using the Polar® Loop tracking system. | Behavioral: Common intervention components for Lifestyle<br>* Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.<br>|
| Active Comparator: Lifestyle + SB<br>Participants will receive everything that is described in Lifestyle. Additionally, they will be educated on the relationship between SB and weight management, and cancer survivorship risk. The goal will be to reduce sedentary time by > 2 hrs/day or > 14 hrs/wk. Participants will shape towards the goal. Baseline measures will be used as the starting point from where to calculate the 2 hrs/day reduction, providing participants with a total SB goal per day. For example, if baseline measures indicate that a participant has a mean daily SB amount of 9.75 hrs, the participant's SB goal will be 7.75 hrs/day. To achieve that goal, participants will reduce SB by 20 minutes a day, starting week 2, with a decrease of an additional 20 minutes/day occurring weekly until the SB goal is achieved (week 7 of the 12 week intervention. Participants will self-monitor their SB using the Polar® Loop tracking system. | Behavioral: Common intervention components for Lifestyle<br>* Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.<br>|
| No Intervention: Newsletter<br>Participants in this condition will receive standard care and every month they will receive a newsletter that provides information and tips about healthy eating and activity behaviors. This newsletter will include information on myPlate,28 activity guidelines,29 reading food labels, healthy recipes, and seasonal activity suggestions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of activity by Armband | Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day. | change from baseline to 12 weeks | 
| Weight | Weight will be assessed by an electronic scale. | change from baseline to 12 weeks | 
| Measures of diet | Diet will be assessed by 3-day food records (2 weekdays and 1 weekend day). Each record will be completed using the Nutrition Data System Software for Research (NDS-R) developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota. | change from baseline to 12 weeks | 
| Fitness (The 6 Minute Walk Test (6MWT)) | The 6 Minute Walk Test (6MWT) is well tolerated by participants who are obese. Participants will walk as quickly as possible, without jogging or running, around two cones placed 60 m apart for 6 min. The primary measure will be distance walked. The 6MWT has been significantly correlated to peak oxygen uptake (VO2) values from a cycle ergometer test (r = .73, p < 0.001). The 6MWT has been shown to measure enhanced physical performance beyond that which occurs from weight loss itself in participants with obesity. Standard safety protocols will be used for participants that Dr. Bell considers appropriate for testing. | change from baseline to 12 weeks | 
| Physical activity by Questionnaire | Participants will complete the Past-day Adults' Sedentary Time (PAST), a seven-item questionnaire that asks questions about sedentary behaviors that have occurred during the previous day. | change from baseline to 12 weeks | 
| Insulin | Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures. | change from baseline to 12 weeks | 
| Glucose | Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures. | change from baseline to 12 weeks | 
| Leptin | Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures. | change from baseline to 12 weeks | 
| C-Reactive Protein | Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures. | change from baseline to 12 weeks | 
| Height | Height will be assessed using a stadiometer at baseline | baseline | 
| BMI | BMI (kg/m2) will be calculated from height and weight measurements. | change from baseline to 12 weeks | 
| Waist circumference | waist measurement | change from baseline to 12 weeks | 
| Percent body fat | Percent body fat will be assessed by bioelectrical impedance analysis (BIA), using the foot to foot pressure contact electrode BIA technique (Tanita TBF-300A model) following standard protocol | change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of self-monitoring records | Number of weekly records of self-monitoring of diet and activity completed and turned in. | 12 weeks |