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

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.

Study Overview

• Status: Completed
• Conditions: Female Breast Cancer
• Intervention / Treatment: Behavioral: Home-based exercise intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based aerobic exercise training; 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.	Behavioral: Home-based exercise intervention; A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.
Active Comparator: Home-based standard attention flexibility/toning control; Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.	Behavioral: Home-based exercise intervention; A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.

What is the study measuring?

Primary Outcome Measures

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Feasibility - Attrition rates	Feasibility measure of the number of participants who dropout or are withdrawn	Throughout 10 week study period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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of gut microbiota as measured by fecal samples	Using standard diversity and taxa comparison metrics	Baseline
Composition of gut microbiota as measured by fecal samples	Using standard diversity and taxa comparison metrics	5 weeks after baseline
Composition of gut microbiota as measured by fecal samples	Using standard diversity and taxa comparison metrics	10 weeks after baseline
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	Baseline
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	5 weeks after baseline
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	10 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)	Motion sensor measures physical activity not observed during intervention activities	Baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)	Motion sensor measures physical activity not observed during intervention activities	5 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)	Motion sensor measures physical activity not observed during intervention activities	10 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale	Measurement of body fat percentage (0-100%) where a lower percentage is better.	Baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale	Measurement of body fat percentage (0-100%) where a lower percentage is better.	5 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale	Measurement of body fat percentage (0-100%) where a lower percentage is better.	10 weeks after baseline
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.	Baseline
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.	5 weeks after baseline
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.	10 weeks after baseline
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.	Baseline
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.	5 weeks after baseline
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.	10 weeks after baseline
Change in physical performance	Participants will complete a 2-minute step test measured by study staff through videoconference	Baseline
Change in physical performance	Participants will complete a 2-minute step test measured by study staff through videoconference	5 weeks after baseline
Change in physical performance	Participants will complete a 2-minute step test measured by study staff through videoconference	10 weeks after baseline
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	Baseline
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	5 weeks after baseline
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	10 weeks after baseline
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	Baseline
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	5 weeks after baseline
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	10 weeks after baseline
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	Baseline
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	5 weeks after baseline
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	10 weeks after baseline
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	Baseline
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	5 weeks after baseline
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	10 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Laura Rogers, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer; Cancer; Microbiome; Aerobic Exercise; Gut Microbiome; Female Breast Cancer; Flexibility Exercise
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 300007016; BCRFA (Other Identifier: Breast Cancer Research Foundation of Alabama)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No