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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Female Breast Cancer

Intervention / Treatment
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* Behavioral: Home-based exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based aerobic exercise training<br>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<br>* A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.<br>|
| Active Comparator: Home-based standard attention flexibility/toning control<br>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<br>* A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Gut Microbiome, Breast Cancer, Cancer, Aerobic Exercise, Microbiome, Female Breast Cancer, Flexibility Exercise