Understanding and Predicting Breast Cancer Events After Treatment
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: Cardiac MRI
- Registration Number
- NCT02791581
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
- Detailed Description
840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged \< 52 vs. \> 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.
Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 403
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breast Cancer Patients Cardiac MRI Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment. Non-Cancer Controls Cardiac MRI Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.
- Primary Outcome Measures
Name Time Method Change in FACT-Fatigue Results Baseline, 3 months, 12 months and 24 months Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in 6 Minute Walk Results Baseline, 3 months, 12 months and 24 months The purpose of this test is to find out how far the participant can walk in 6 minutes.
FACT-Fatigue Baseline Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in MRI Exam Results Baseline, 3 months and 24 months The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.
- Secondary Outcome Measures
Name Time Method Cook-Medley Hostility Scale Baseline A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.
Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.6 Minute Walk Results Baseline, 3 months, 12 months and 24 months The purpose of this test is to find out how far the participant can walk in 6 minutes.
RAND MOS 36-item Short Form Health Survey (SF-36) Baseline, 3 months, 12 months and 24 months SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.
PACE Adult Sedentary Behaviors Survey Baseline, 3 months, 12 months and 24 months Assess sedentary lifestyle behaviors
Cohen's 4-item Perceived Stress Scale (PSS) Baseline, 3 months, 12 months, and 24 months A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often)
o weeks four aspects of stress were experienced (1=never to 5=very often)Walking Efficacy for Duration Scale Baseline, 3 months, 12 months and 24 months Comprised of six items and will be included as a measure of exercise capacity
Standing Balance Test Baseline, 3 months, 12 months and 24 months Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.
Godin Leisure-Time Exercise Questionnaire (LTEQ) Baseline, 3 months, 12 months and 24 months Main process measure of physical activity participation
KCCQ-12 Questionnaire Baseline, 24 months Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.
Changes in FACT-Fatigue Results Baseline, 3 months, 12 months, and 24 months Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Center for Epidemiological Studies Depression Scale (CESD-10) Baseline, 3 months, 12 months and 24 months Screening questionnaire assessing depressive symptoms during the last week
PROMIS Short Form 8A Measure of Sleep Disturbance Baseline, 3 months, 12 months and 24 months Assess time course and risk factors associated with sleep disturbance and fatigue
Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.Chair Stands - Measures Leg Strength Baseline, 3 months, 12 months and 24 months Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.
Grip Strength Baseline, 3 months, 12 months and 24 months Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.
PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A Baseline, 3 months, 12 months and 24 months Measurement of different aspects of cognitive functioning.
PROMIS Applied Cognitive Abilities Short Form 8A
- Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.
Applied Cognition General Concerns Short Form 8A
- Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.Range of Motion Baseline, 3 months, 12 months and 24 months Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.
Gait Speed Test Baseline, 3 months, 12 months and 24 months Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.
Trial Locations
- Locations (66)
Beaumont Hospital - Farmington Hills
🇺🇸Farmington Hills, Michigan, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Novant Health Presbyterian Medical Center
🇺🇸Charlotte, North Carolina, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Beaumont Hospital - Dearborn
🇺🇸Dearborn, Michigan, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
University of Kansas Hospital-Westwood Cancer Center
🇺🇸Westwood, Kansas, United States
Randolph Hospital
🇺🇸Asheboro, North Carolina, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Prisma Health Cancer Institute - Seneca
🇺🇸Seneca, South Carolina, United States
Aurora Cancer Care-Kenosha South
🇺🇸Kenosha, Wisconsin, United States
Cone Health Cancer Center at Alamance Regional
🇺🇸Burlington, North Carolina, United States
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
🇺🇸Lynchburg, Virginia, United States
Shenandoah Oncology PC
🇺🇸Winchester, Virginia, United States
Aurora Medical Center in Summit
🇺🇸Summit, Wisconsin, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
🇺🇸Harrisburg, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Washington Medical Center - Montlake
🇺🇸Seattle, Washington, United States
IU Health North Hospital
🇺🇸Carmel, Indiana, United States
Springmill Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Prisma Health Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
UPMC Memorial
🇺🇸York, Pennsylvania, United States
Prisma Health Cancer Institute - Easley
🇺🇸Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Aurora Health Center-Fond du Lac
🇺🇸Fond Du Lac, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
🇺🇸Burlington, Wisconsin, United States
Aurora Health Care Germantown Health Center
🇺🇸Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
🇺🇸Grafton, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
🇺🇸Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
🇺🇸Racine, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
🇺🇸Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
🇺🇸Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
🇺🇸Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Moffitt Cancer Center - McKinley Campus
🇺🇸Tampa, Florida, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Newton Medical Center
🇺🇸Newton, New Jersey, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Aurora Cancer Care-Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Health Partners Inc
🇺🇸Minneapolis, Minnesota, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States