Back to resultsDeveloping a Healthy Lifestyle in Breast Cancer Survivors
Primary Purpose
Breast Cancer, Sedentary Lifestyle
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Common intervention components for Lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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).
Sites / Locations
- Healthy Eating and Activity Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Lifestyle
Lifestyle + SB
Newsletter
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Measures of activity by Armband
Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day.
Weight
Weight will be assessed by an electronic scale.
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.
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.
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.
Insulin
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Glucose
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Leptin
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
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.
Height
Height will be assessed using a stadiometer at baseline
BMI
BMI (kg/m2) will be calculated from height and weight measurements.
Waist circumference
waist measurement
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
Secondary Outcome Measures
Completion of self-monitoring records
Number of weekly records of self-monitoring of diet and activity completed and turned in.
Full Information
NCT ID
NCT02677857
First Posted
January 25, 2016
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT02677857
Brief Title
Developing a Healthy Lifestyle in Breast Cancer Survivors
Official Title
Developing a Healthy Lifestyle in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment efforts were not effective.
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sedentary Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lifestyle + SB
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Newsletter
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Common intervention components for Lifestyle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measures of activity by Armband
Description
Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day.
Time Frame
change from baseline to 12 weeks
Title
Weight
Description
Weight will be assessed by an electronic scale.
Time Frame
change from baseline to 12 weeks
Title
Measures of diet
Description
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.
Time Frame
change from baseline to 12 weeks
Title
Fitness (The 6 Minute Walk Test (6MWT))
Description
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.
Time Frame
change from baseline to 12 weeks
Title
Physical activity by Questionnaire
Description
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.
Time Frame
change from baseline to 12 weeks
Title
Insulin
Description
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Time Frame
change from baseline to 12 weeks
Title
Glucose
Description
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Time Frame
change from baseline to 12 weeks
Title
Leptin
Description
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Time Frame
change from baseline to 12 weeks
Title
C-Reactive Protein
Description
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Time Frame
change from baseline to 12 weeks
Title
Height
Description
Height will be assessed using a stadiometer at baseline
Time Frame
baseline
Title
BMI
Description
BMI (kg/m2) will be calculated from height and weight measurements.
Time Frame
change from baseline to 12 weeks
Title
Waist circumference
Description
waist measurement
Time Frame
change from baseline to 12 weeks
Title
Percent body fat
Description
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
Time Frame
change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Completion of self-monitoring records
Description
Number of weekly records of self-monitoring of diet and activity completed and turned in.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie Raynor
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Eating and Activity Laboratory
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Developing a Healthy Lifestyle in Breast Cancer Survivors
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