Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on expression of tumor molecular molecules, insulin levels, and estradiol levels.
Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway|
- Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs. [ Time Frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months ] [ Designated as safety issue: No ]To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention
- Secondary objectives: Time to progression [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]goal-setting intervention versus standard of care: Time to progression
- Change in Body Mass Index (BMI) [ Time Frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months ] [ Designated as safety issue: No ]
- Health related quality of life [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]As measured by questionnaires: FACIT-F and diet survey
- Correlative Science outcomes in peripheral blood [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]serum estradiol and fasting insulin levels
- Correlative science outcomes in tissue biopsies [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]relative protein expression of Lipoprotein Lipase (LPL), Cluster of Differentiation 36 (CD36), Spot 14 and fatty acid synthase (FASN) of the original tumor to the metastatic tumor at baseline and at the end of the study.
- correlative science in >= 22500 steps [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]Compare correlative science outcomes in those who achieve greater than or equal to 22500 steps/ week to those who do not.
- participants who achieve >= 22500 steps/week [ Time Frame: 6 months ] [ Designated as safety issue: No ]Determine the proportion of participants who are able to achieve greater than or equal to 22,500 steps/week
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A-Pedometer and Goal setting
Physical Activity Goal Setting
Patients receive physical therapy (PT) consult, educational materials, and telephone calls and are contacted weekly/monthly for physical activity (PA) goal setting with registered nurse (RN). Physical Activity completed is measured with pedometers and recorded on patient log.
Behavioral: Physical Activity Goal Setting
Will include an initial physical therapy (PTA) consult to set exercise goals to increase physical activity by 6000 steps per week over the course of the trial, viewing of the "Exercise and Breast Cancer" digital video disc (DVD, followed by 10 regular phone calls or RN visits (weekly for the first month, then monthly) to follow up on whether or not those goals are being met and, if not, how best to meet them.
No Intervention: ARM B
Patients receive standard physical activity recommendations and follow up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653366
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Mary Chamberlin, MD||Dartmouth-Hitchcock Medical Center|