Back to resultsGut Microbe Composition, Exercise, and Breast Breast Cancer Survivors (ROME)
Primary Purpose
Breast Cancer, Gut Microbiome, Exercise
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Training
Attention Control
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, fatigue, exercise, psychosocial outcomes, inflammation, gut microbiome
Eligibility Criteria
Inclusion criteria:
- Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
- ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
- Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
- English speaking,
- Physician medical clearance for study participation,
- Able to ambulate without assistance,
- No antibiotics for the past 90 days,
- Willing to avoid taking probiotics for the duration of the study
- Peak VO2 <30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
Exclusion criteria:
- Metastatic or recurrent cancer
- Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3) unstable angina
- New York Heart Association class II, III, or IV congestive heart failure
- Uncontrolled asthma
- Interstitial lung disease
- Current steroid use
- Having been 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 (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
- Anticipate elective surgery during the study period
- Anticipate changes in usual medications during the study period
- Plan to move residence out of the local area during the study period
- Plan to travel out of the local area for >1 week during study participation
- Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
- Currently pregnant or anticipate pregnancy during study participation
- Live or work >50 miles from study site or do not have transportation to study site
- BMI >50
- Anticipate needing antibiotics during the study period
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic Exercise Training
Attention Control
Arm Description
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
Outcomes
Primary Outcome Measures
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
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Secondary Outcome Measures
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Systemic inflammation tested via biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Systemic inflammation tested via blood biomarkers
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Autonomic nervous system measured through non-invasive ECG
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Autonomic nervous system measured through non-invasive ECG
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Autonomic nervous system measured through non-invasive ECG
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Autonomic nervous system measured through non-invasive ECG
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
Concentration of cortisol measured through hair sample
Hormone change that is associated with stress
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
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
Full Information
NCT ID
NCT04088708
First Posted
August 3, 2019
Last Updated
November 14, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04088708
Brief Title
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
Acronym
ROME
Official Title
Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.
Detailed Description
Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gut Microbiome, Exercise, Fatigue
Keywords
breast cancer, fatigue, exercise, psychosocial outcomes, inflammation, gut microbiome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Assessors will be blinded to participant study group allocation
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise Training
Arm Type
Experimental
Arm Description
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.
Primary Outcome Measure Information:
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
Composition of gut microbiota as measured by fecal samples
Description
Using standard diversity and taxa comparison metrics
Time Frame
15 weeks after baseline
Secondary Outcome Measure Information:
Title
Systemic inflammation tested via blood biomarkers
Description
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Time Frame
Baseline
Title
Systemic inflammation tested via blood biomarkers
Description
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Time Frame
5 weeks after baseline
Title
Systemic inflammation tested via biomarkers
Description
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Time Frame
10 weeks after baseline
Title
Systemic inflammation tested via blood biomarkers
Description
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Time Frame
15 weeks after baseline
Title
Autonomic nervous system measured through non-invasive ECG
Description
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Time Frame
Baseline
Title
Autonomic nervous system measured through non-invasive ECG
Description
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Time Frame
5 weeks after baseline
Title
Autonomic nervous system measured through non-invasive ECG
Description
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Time Frame
10 weeks after baseline
Title
Autonomic nervous system measured through non-invasive ECG
Description
Using a Biopac MP 160 to measure heart rate variability and impedance cardiography while resting quietly
Time Frame
15 weeks after baseline
Title
Concentration of cortisol measured through hair sample
Description
Hormone change that is associated with stress
Time Frame
Baseline
Title
Concentration of cortisol measured through hair sample
Description
Hormone change that is associated with stress
Time Frame
5 weeks after baseline
Title
Concentration of cortisol measured through hair sample
Description
Hormone change that is associated with stress
Time Frame
10 weeks after baseline
Title
Concentration of cortisol measured through hair sample
Description
Hormone change that is associated with stress
Time Frame
15 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
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
15 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Description
Cardiorespiratory fitness test on a treadmill
Time Frame
Baseline
Title
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Description
Cardiorespiratory fitness test on a treadmill
Time Frame
5 weeks after baseline
Title
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Description
Cardiorespiratory fitness test on a treadmill
Time Frame
10 weeks after baseline
Title
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Description
Cardiorespiratory fitness test on a treadmill
Time Frame
15 weeks after baseline
Title
Walking Economy measured via 6 minute treadmill test
Description
Fitness test on a treadmill
Time Frame
Baseline
Title
Walking Economy measured via 6 minute treadmill test
Description
Fitness test on a treadmill
Time Frame
5 weeks after baseline
Title
Walking Economy measured via 6 minute treadmill test
Description
Fitness test on a treadmill
Time Frame
10 weeks after baseline
Title
Walking Economy measured via 6 minute treadmill test
Description
Fitness test on a treadmill
Time Frame
15 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
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
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Description
Motion sensor measures physical activity not observed during intervention activities
Time Frame
15 weeks after baseline
Title
Body composition using a dual energy x-ray absorptiometry
Description
Measurement of body composition
Time Frame
Baseline
Title
Body composition using a dual energy x-ray absorptiometry
Description
Measurement of body composition
Time Frame
5 weeks after baseline
Title
Body composition using a dual energy x-ray absorptiometry
Description
Measurement of body composition
Time Frame
10 weeks after baseline
Title
Body composition using a dual energy x-ray absorptiometry
Description
Measurement of body composition
Time Frame
15 weeks after baseline
Title
FACT-B self-administered survey measuring quality of life
Description
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
Time Frame
Baseline
Title
FACT-B self-administered survey measuring quality of life
Description
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
Time Frame
5 weeks after baseline
Title
FACT-B self-administered survey measuring quality of life
Description
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
Time Frame
10 weeks after baseline
Title
FACT-B self-administered survey measuring quality of life
Description
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
Time Frame
15 weeks after baseline
Title
Self-efficacy by self-administered survey
Description
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
Time Frame
Baseline
Title
Self-efficacy by self-administered survey
Description
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
Time Frame
6 weeks after baseline
Title
Self-efficacy by self-administered survey
Description
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
Time Frame
10 weeks after baseline
Title
Self-efficacy by self-administered survey
Description
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
Time Frame
15 weeks after baseline
Title
Self-administered survey measuring mood and stress
Description
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
Time Frame
Baseline
Title
Self-administered survey measuring mood and stress
Description
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
Time Frame
5 weeks after baseline
Title
Self-administered survey measuring mood and stress
Description
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
Time Frame
10 weeks after baseline
Title
Self-administered survey measuring mood and stress
Description
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
Time Frame
15 weeks after baseline
Title
Self-administered survey measuring memory
Description
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
Time Frame
Baseline
Title
Self-administered survey measuring memory
Description
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
Time Frame
5 weeks after baseline
Title
Self-administered survey measuring memory
Description
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
Time Frame
10 weeks after baseline
Title
Self-administered survey measuring memory
Description
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
Time Frame
15 weeks after baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
English speaking,
Physician medical clearance for study participation,
Able to ambulate without assistance,
No antibiotics for the past 90 days,
Willing to avoid taking probiotics for the duration of the study
Peak VO2 <30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
Exclusion criteria:
Metastatic or recurrent cancer
Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3) unstable angina
New York Heart Association class II, III, or IV congestive heart failure
Uncontrolled asthma
Interstitial lung disease
Current steroid use
Having been 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 (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
Anticipate elective surgery during the study period
Anticipate changes in usual medications during the study period
Plan to move residence out of the local area during the study period
Plan to travel out of the local area for >1 week during study participation
Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
Currently pregnant or anticipate pregnancy during study participation
Live or work >50 miles from study site or do not have transportation to study site
BMI >50
Anticipate needing antibiotics during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Q Rogers, MD, MPH
Phone
(205) - 934 - 9735
Ext
2059349735
Email
rogersl@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ildiko Nyikos, M.A., ACSM-RCEP
Phone
(205) - 975-0002
Email
inyikos@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, MD, MPH
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
35294-001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, MD, MPH
Phone
(205) 934-9735
Email
rogersl@uab.edu
First Name & Middle Initial & Last Name & Degree
Ildiko Nyikos, M.A., ACSM-RCEP
Phone
2059750002
Email
inyikos@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, MD
First Name & Middle Initial & Last Name & Degree
Gary Hunter, PhD
First Name & Middle Initial & Last Name & Degree
Bulent Turan, PhD
First Name & Middle Initial & Last Name & Degree
Helen Krontiras, MD
First Name & Middle Initial & Last Name & Degree
Elliot Lefkowitz, PhD
First Name & Middle Initial & Last Name & Degree
Robert Motl, PhD
First Name & Middle Initial & Last Name & Degree
Nianjun Liu, PhD
First Name & Middle Initial & Last Name & Degree
Stephen J Carter, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.
IPD Sharing Time Frame
To be determined
IPD Sharing Access Criteria
To be determined
Learn more about this trial
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
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