Developing a Healthy Lifestyle in Breast Cancer Survivors
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | January 2016 |
| End Date: | December 2016 |
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.
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.
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).
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