Clinical trial · Interventional
iMETX (Individualized Metabolic RX): a Pilot Study
iMETX (Individualized Metabolic RX): a Pilot Study of an Environmental Intervention to Increase Energy Expenditure Among Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iMETX intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iMETX intervention
- description
- Individualized exercise recommendation
- interventionNames
- Behavioral: iMETX intervention
Primary outcomes (1)
- measure
- Feasibility of intervention
- timeFrame
- 24 months
- description
- Percent of enrolled patients who complete study through end of intervention period (week 4-week 15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Age ≥ 18 years 2. Diagnosis of DCIS or stage I, II, or III breast cancer 3. 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 4. Body weight less than 350 lbs., as dictated by the weight limit for DXA scanner 5. Regular access to a smart phone or computer Exclusion criteria 1. 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 2. Locally recurrent or metastatic breast cancer 3. Diagnosis of other active malignancy. Prior treated malignancies in addition to breast cancer are acceptable. 4. Pregnancy 5. Requirement of assistive devices (e.g., cane) for ambulation 6. Plans for moving to a new home or workplace during, pre-, or post-intervention period 7. Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast reconstruction) 8. Inability to comply with the study procedures
References
Publications (1)
- DERIVEDBallinger 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