Developing a Healthy Lifestyle in Breast Cancer Survivors

NCT ID: NCT02677857

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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:

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.

Conditions

Breast Cancer; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lifestyle

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.

Group Type: ACTIVE_COMPARATOR

Common intervention components for Lifestyle

Intervention Type: BEHAVIORAL

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.

Lifestyle + SB

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.

Group Type: ACTIVE_COMPARATOR

Common intervention components for Lifestyle

Intervention Type: BEHAVIORAL

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.

Newsletter

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Hollie Raynor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hollie Raynor

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

UTKIRB-15-02602-FB

Identifier Type: -

Identifier Source: org_study_id