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Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations (EMBRACE)

Primary Purpose

Female Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based exercise intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Female Breast Cancer focused on measuring Exercise, Gut Microbiome, Breast Cancer, Cancer, Aerobic Exercise, Microbiome, Female Breast Cancer, Flexibility Exercise

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-Hispanic white or black women
  • Age 18-70 years
  • History of breast cancer stage 0, I, II, or III
  • ≥1 year post-primary cancer treatment completion
  • English speaking
  • Ambulates without assistance
  • No antibiotics in past 90 days
  • Willing to avoid taking probiotics during the study
  • Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
  • Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots)

Exclusion Criteria:

  • Metastatic or recurrent cancer
  • Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current steroid use
  • Told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease
  • Participating in >30 minutes of exercise on ≥3 days/week in the past six months
  • Anticipate elective surgery, medication changes or antibiotics during the study
  • Contraindication to ≥moderate intensity aerobic exercise
  • Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise
  • Breastfeeding, pregnant or anticipate pregnancy during the study
  • Plan to move residence during the study
  • Plan to travel for more than 1 week during the study
  • Anticipate trouble attending the weekly study videoconference calls
  • History of bariatric surgery
  • Diabetes
  • Body weight greater than 440 lbs

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based aerobic exercise training

Home-based standard attention flexibility/toning control

Arm Description

home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness.

Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.

Outcomes

Primary Outcome Measures

Feasibility - Recruitment
Number of participants excluded or not agreeing to participate will be measured
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Feasibility - Attrition rates
Feasibility measure of the number of participants who dropout or are withdrawn
Feasibility - Adverse events
Feasibility measure of the number of adverse events recorded by staff during the study period
Feasibility - Participant satisfaction
Self-Administered survey given to the participant at the conclusion of the 10 week study period

Secondary Outcome Measures

Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD

Full Information

First Posted
August 3, 2021
Last Updated
March 16, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05000502
Brief Title
Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Acronym
EMBRACE
Official Title
Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.
Detailed Description
Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Cancer
Keywords
Exercise, Gut Microbiome, Breast Cancer, Cancer, Aerobic Exercise, Microbiome, Female Breast Cancer, Flexibility Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 breast cancer survivors will be randomized (like flipping a coin) to one of two study conditions: 1) home-based aerobic exercise training (with aerobic exercise progression targeting improved cardiorespiratory fitness) or 2) standard attention control (stretching exercises). All participants will be asked to maintain their usual diet and avoid change in body weight during the study.
Masking
Outcomes Assessor
Masking Description
Staff doing assessments will be masked to study group allocation
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based aerobic exercise training
Arm Type
Experimental
Arm Description
home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness.
Arm Title
Home-based standard attention flexibility/toning control
Arm Type
Active Comparator
Arm Description
Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.
Intervention Type
Behavioral
Intervention Name(s)
Home-based exercise intervention
Intervention Description
A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Number of participants excluded or not agreeing to participate will be measured
Time Frame
Baseline
Title
Feasibility - Adherence to study protocol activities
Description
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Time Frame
Throughout 10 week study period
Title
Feasibility - Attrition rates
Description
Feasibility measure of the number of participants who dropout or are withdrawn
Time Frame
Throughout 10 week study period
Title
Feasibility - Adverse events
Description
Feasibility measure of the number of adverse events recorded by staff during the study period
Time Frame
Throughout 10 week study period
Title
Feasibility - Participant satisfaction
Description
Self-Administered survey given to the participant at the conclusion of the 10 week study period
Time Frame
At conclusion of 10 week study period
Secondary Outcome Measure Information:
Title
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Description
Motion sensor measures physical activity not observed during intervention activities
Time Frame
Baseline
Title
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Description
Motion sensor measures physical activity not observed during intervention activities
Time Frame
5 weeks after baseline
Title
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Description
Motion sensor measures physical activity not observed during intervention activities
Time Frame
10 weeks after baseline
Title
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time Frame
Baseline
Title
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time Frame
5 weeks after baseline
Title
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time Frame
10 weeks after baseline
Title
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time Frame
Baseline
Title
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time Frame
5 weeks after baseline
Title
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time Frame
10 weeks after baseline
Title
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time Frame
Baseline
Title
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time Frame
5 weeks after baseline
Title
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Description
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time Frame
10 weeks after baseline
Title
Change in physical performance
Description
Participants will complete a 2-minute step test measured by study staff through videoconference
Time Frame
Baseline
Title
Change in physical performance
Description
Participants will complete a 2-minute step test measured by study staff through videoconference
Time Frame
5 weeks after baseline
Title
Change in physical performance
Description
Participants will complete a 2-minute step test measured by study staff through videoconference
Time Frame
10 weeks after baseline
Title
Composition of gut microbiota as measured by fecal samples
Description
Using standard diversity and taxa comparison metrics
Time Frame
Baseline
Title
Composition of gut microbiota as measured by fecal samples
Description
Using standard diversity and taxa comparison metrics
Time Frame
5 weeks after baseline
Title
Composition of gut microbiota as measured by fecal samples
Description
Using standard diversity and taxa comparison metrics
Time Frame
10 weeks after baseline
Title
Fatigue measured through fatigue specific questionnaire
Description
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time Frame
Baseline
Title
Fatigue measured through fatigue specific questionnaire
Description
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time Frame
5 weeks after baseline
Title
Fatigue measured through fatigue specific questionnaire
Description
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time Frame
10 weeks after baseline
Title
Depression and Anxiety measured through specific questionnaire
Description
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time Frame
Baseline
Title
Depression and Anxiety measured through specific questionnaire
Description
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time Frame
5 weeks after baseline
Title
Depression and Anxiety measured through specific questionnaire
Description
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time Frame
10 weeks after baseline
Title
Sleep dysfunction measured through specific questionnaire
Description
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time Frame
Baseline
Title
Sleep dysfunction measured through specific questionnaire
Description
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time Frame
5 weeks after baseline
Title
Sleep dysfunction measured through specific questionnaire
Description
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time Frame
10 weeks after baseline
Title
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Description
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time Frame
Baseline
Title
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Description
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time Frame
5 weeks after baseline
Title
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Description
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time Frame
10 weeks after baseline
Title
Post-traumatic stress measured through specific questionnaire
Description
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time Frame
Baseline
Title
Post-traumatic stress measured through specific questionnaire
Description
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time Frame
5 weeks after baseline
Title
Post-traumatic stress measured through specific questionnaire
Description
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time Frame
10 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-Hispanic white or black women Age 18-70 years History of breast cancer stage 0, I, II, or III ≥1 year post-primary cancer treatment completion English speaking Ambulates without assistance No antibiotics in past 90 days Willing to avoid taking probiotics during the study Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.) Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots) Exclusion Criteria: Metastatic or recurrent cancer Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ) Unstable angina New York Heart Association class II, III, or IV congestive heart failure Uncontrolled asthma Interstitial lung disease Current steroid use Told by a physician to only do exercise prescribed by a physician Dementia or organic brain syndrome Schizophrenia or active psychosis Connective tissue or rheumatologic disease Participating in >30 minutes of exercise on ≥3 days/week in the past six months Anticipate elective surgery, medication changes or antibiotics during the study Contraindication to ≥moderate intensity aerobic exercise Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise Breastfeeding, pregnant or anticipate pregnancy during the study Plan to move residence during the study Plan to travel for more than 1 week during the study Anticipate trouble attending the weekly study videoconference calls History of bariatric surgery Body weight greater than 440 lbs Any social, psychological, or physical condition that interferes with the participant's ability to complete study activities or unduly increases study risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Rogers, MD
Phone
2059349735
Email
lqrogers@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Rogers, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Roughsedge, RD
Email
vlroughsedge@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share participant data.

Learn more about this trial

Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations

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