Breast CancerNCT03158519
iMETX (Individualized Metabolic RX): a Pilot Study
A study testing iMETX intervention in people with Breast Cancer, run by Indiana University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- iMETX intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 May 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Health North Hospital
Carmel, Indiana, 46032
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Spring Mill Medical Center
Indianapolis, Indiana, 46290
About this study
Official title: iMETX (Individualized Metabolic RX): a Pilot Study of an Environmental Intervention to Increase Energy Expenditure Among Breast Cancer Survivors
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.
Read the detailed description
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
- Determine a preliminary estimate of effect size of the environmental intervention on energetic capacity (power envelope) as measured by Power Protocol-B
- Determine a preliminary estimate of effect size of the environmental intervention on average daily EE as measured by a wearable hybrid GPS/accelerometer physical activity monitor
- Determine the effect of the environment intervention on the physical parameters of BMI and lean body mass
- Determine the effect of the environmental intervention on patient reported fatigue and quality of life
- Determine the persistence of changes in average daily EE after the intervention is complete (i.e., when individual movement tasks are no longer suggested).
- Obtain formal and informal patient feedback throughout and after the intervention to assess satisfaction and perceptions of feasibility
- Assess safety
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.
- Conditions
- Breast Cancer
- Being tested
- iMETX intervention
- Keywords
- Physical activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMETX interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iMETX intervention | Experimental | Individualized exercise recommendation Receives: Behavioral: iMETX intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Percent of enrolled patients who complete study through end of intervention period (week 4-week 15)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 May 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Kathy Miller, Indiana University
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158519
- Sponsor's protocol ID
- IUSCC-0590
- Status last verified
- Feb 2020
- First submitted
- 16 May 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33912450
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMETX (Individualized Metabolic RX): a Pilot Study of an Environmental Intervention to Increase Energy Expenditure Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03158519
- Acronym / sponsor ID
- IUSCC-0590
- Conditions
- Breast Cancer
- Keywords
- Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, University of Wisconsin, Madison
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Determine a preliminary estimate of effect size of the environmental intervention on energetic capacity (power envelope) as measured by Power Protocol-B
- Determine a preliminary estimate of effect size of the environmental intervention on average daily EE as measured by a wearable hybrid GPS/accelerometer physical activity monitor
- Determine the effect of the environment intervention on the physical parameters of BMI and lean body mass
- Determine the effect of the environmental intervention on patient reported fatigue and quality of life
- Determine the persistence of changes in average daily EE after the intervention is complete (i.e., when individual movement tasks are no longer suggested).
- Obtain formal and informal patient feedback throughout and after the intervention to assess satisfaction and perceptions of feasibility
- Assess safety
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iMETX intervention | Experimental | Behavioral: iMETX interventionIndividualized exercise recommendation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iMETX interventionPre-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. | Behavioural | iMETX intervention |
Primary outcome
Feasibility of intervention
Time frame: 24 months
Percent of enrolled patients who complete study through end of intervention period (week 4-week 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 33912450Ballinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Miller, MD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iMETX intervention in people with Breast Cancer, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.