iMETX (Individualized Metabolic RX): a Pilot Study

NCT03158519 | Completed DMC

• 1 other identifier: IUSCC-0590
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

• Feasibility of intervention

  Percent of enrolled patients who complete study through end of intervention period (week 4-week 15)

  24 months

Study Arms (1)

iMETX intervention

EXPERIMENTAL

Individualized exercise recommendation

Behavioral: iMETX intervention

Interventions

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.

iMETX intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead
• Susan G. Komen Breast Cancer Foundation: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (4)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Spring Mill Medical Center

Indianapolis, Indiana, 46290, United States

Location

Related Publications (1)

• 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.

  PMID: 33912450 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Kathy Miller, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: May 15, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)