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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
| University of Wisconsin, Madison | OTHER |
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The purpose of this study is to test the mechanics and feasibility of delivering an individualized intervention to increase physical activity in breast cancer survivors.
In this study, researchers will test an intervention that uses a commonly worn activity monitor (i.e., global positioning system [GPS] enabled running watch) to see if they can "prescribe" specific ways to increase physical activity that are individually tailored to each participant. The goal is to help participants increase their daily physical activity without having to join a gym or other traditional fitness program. Researchers want to see if they can make specific recommendations (using an application that can be added to a cell phone, tablet and/or computer) on ways participants can slowly increase their activity based upon where they live and work and in a way that is tailored individually to them. For example, participants may be given a route to walk on their lunch break, or new place to park to allow for a longer walk to their job. The goal is to meet participants where they are in their current level of fitness, and to help them think of new and creative ways of increasing activity without the frustration of soreness or risk of injury. As they move more, the recommendations will increase with them.
Objectives The investigators hypothesize that developing an individualized and dynamic exercise intervention (iMETX) that accounts for factors of the built environment will be feasible for breast cancer patients following primary treatment. This pilot study will assess the feasibility and provide preliminary estimates of effectiveness of the environmental intervention for increasing the energy expenditure and energetic capacity of breast cancer patients. The investigators will also explore patient feedback with this intervention and changes in levels of fatigue and quality of life. Experience and data from this initial pilot study will be used to refine the intervention and design subsequent studies to test its effectiveness.
Primary objective Evaluate the feasibility of an individualized, dynamic, environmental physical activity intervention for early stage breast cancer patients following primary treatment.
Secondary objectives
Exploratory objectives Blood samples will be collected prior to and following the intervention and banked for future correlative studies, including the following: inflammatory cytokines (high sensitivity C reactive protein and interleukin 6), adipokines (adiponectin and leptin), sex hormones (estradiol, estrone, testosterone, and sex hormone binding globulin), and telomere length. In addition the invstigators will explore correlations of built and social environment characteristics and psychosocial characteristics with pre-intervention and changes in energy expenditure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iMETX intervention | Experimental | Individualized exercise recommendation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iMETX intervention | Behavioral | Pre-intervention the participants will wear the running watch for 3 weeks so that researchers can collect data about their daily routines regarding where and how much energy they expend. During the intervention participants will wear the running watch for 12 weeks. Every 1-3 days the participants will be given an individualized recommendation for how to increase their activity via the iMETX application. Participants will be able to provide feedback to the researchers throughout intervention period regarding what works and does not in terms of the recommendations for increasing activity. Post-intervention the participants will wear the running watch for 12 weeks so that researchers can collect data in order to determine whether physical activity changes made during the intervention are sustained. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intervention | Percent of enrolled patients who complete study through end of intervention period (week 4-week 15) | 24 months |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health North Hospital | Carmel | Indiana | 46032 | United States | ||
| Indiana University Health Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33912450 | Derived | Ballinger TJ, Althouse SK, Olsen TP, Miller KD, Sledge JS. A Personalized, Dynamic Physical Activity Intervention Is Feasible and Improves Energetic Capacity, Energy Expenditure, and Quality of Life in Breast Cancer Survivors. Front Oncol. 2021 Apr 12;11:626180. doi: 10.3389/fonc.2021.626180. eCollection 2021. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Spring Mill Medical Center | Indianapolis | Indiana | 46290 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |