iMETX (Individualized Metabolic RX): a Pilot Study

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03158519

Run by

Indiana University

People needed

64

Starts

2017-05-15

Expected to finish

2019-04-01

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of DCIS or stage I, II, or III breast cancer
• Completion of all primary therapy (with the exception of ongoing endocrine or trastuzumab therapy), including surgery, radiation, and/or chemotherapy greater than 4 weeks prior to study enrollment
• Body weight less than 350 lbs., as dictated by the weight limit for DXA scanner
• Regular access to a smart phone or computer

You may not qualify if…

• Any condition precluding exercise, including: NYHA class II, III, or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, symptomatic anemia, uncontrolled psychiatric conditions such as schizophrenia, or any other comorbidity that would interfere with the ability to complete and comply with the study protocol in the opinion of the investigator
• Locally recurrent or metastatic breast cancer
• Diagnosis of other active malignancy. Prior treated malignancies in addition to breast cancer are acceptable.
• Pregnancy
• Requirement of assistive devices (e.g., cane) for ambulation
• Plans for moving to a new home or workplace during, pre-, or post-intervention period
• Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast reconstruction)
• Inability to comply with the study procedures

Where it is running

• Indiana University Health North Hospital — Carmel, Indiana, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Spring Mill Medical Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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