Developing a Healthy Lifestyle in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Developing a Healthy Lifestyle in Breast Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02677857
• Other study ID #: UTKIRB-15-02602-FB
• Status: Terminated
• Phase: N/A
• First received: January 25, 2016
• Last updated: April 3, 2018
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);

2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or

3. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 65 yrs

2. BMI between 25 and 45 kg/m2

3. history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years

4. completion of initial therapies

5. engage in > 8 hours a day of SB

6. engage in < 100 min/wk MVPA.

Exclusion Criteria:

1. 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)

2. report being unable to walk for 2 blocks (1/4 mile) without stopping

3. report major psychiatric diseases or organic brain syndromes

4. report a serious medical condition in which weight loss is contraindicated

5. 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

6. have had bariatric surgery or are planning to have bariatric surgery in the next 6 months

7. are participating in a program to increase physical activity and/or decrease sedentary time

8. intend to move outside of the metropolitan area within the time frame of the investigation

9. are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation

10. are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition;

11. do not own a smartphone that will run the app required for the Polar® Loop device;

12. are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or

13. 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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sedentary Lifestyle

Intervention

Behavioral:
• Common intervention components for Lifestyle
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.

Locations

Country	Name	City	State
United States	Healthy Eating and Activity Laboratory	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Weight	Weight will be assessed by an electronic scale.	change from baseline to 12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Height	Height will be assessed using a stadiometer at baseline	baseline
Primary	BMI	BMI (kg/m2) will be calculated from height and weight measurements.	change from baseline to 12 weeks
Primary	Waist circumference	waist measurement	change from baseline to 12 weeks
Primary	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	Completion of self-monitoring records	Number of weekly records of self-monitoring of diet and activity completed and turned in.	12 weeks