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Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.

Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Magnetic resonance imaging

Tailored aerobic exercise program onsite and at home.

Physical Activity

Healthy living presentations at a centralized meeting place and over the phone.

Healthy Living

Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Cardiopulmonary Exercise Testing (CPET)

A self-administered 13-item scale to assess fatigue in participants

Questionnaire Administration

William Hundley

This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help doctors predict whether patients will have heart damage caused by chemotherapy in patients with cancer receiving chemotherapy.

Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility of performing the physical activity intervention and the primary outcome measures before, during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma. This study will test the potential for a novel (lifestyle) intervention designed to improve exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This data will inform the development of the R33 phase of the clinical trial to determine if the physical activity intervention can reduce exercise intolerance in this high-risk population. In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac MRI data from individuals in the parent study that did not undergo either of the two interventional arms of this study.

PRIMARY OBJECTIVES:

I. To design an automated MRI hardware/software platform for measuring and reporting left ventricular (LV) function (volumes, strain, and ejection fraction \[EF\]), T1 myocardial signal, and aortic pulse wave velocity (PWV).

II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.

OUTLINE:

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Exercise Capacity Addendum Objectives:

Primary Objective:

* To provide critical participant enrollment data necessary to accomplish the R01 submission, including:
* Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and stage I-IV breast cancer patients including the reasons for failed randomization,
* Identification of barriers for participating in, or adhering to the Patient ES-AI and the Healthy Living Control Group.

Secondary Objective:

• In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum rate of oxygen), and pre-exercise measures of left ventricular and cognitive function, health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment of the left ventricular function and health-related rate quality of life will be attempted in a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the parent study.

For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.

MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 "Early Imaging Detection of Cardiovascular Injury After Cancer"

The number of participants who completed the intervention.

Number of participants who completed the 6-minute walk test at 6-months.

Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.

Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.

Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.

Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.

The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.

The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.

The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.

Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Physical Activity: Tailored aerobic exercise program onsite and at home.

Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants

ADDENDUM: Physical Activity Intervention

Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .

Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.

Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants

ADDENDUM: Healthy Living Instruction Group (Control Arm)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer

Project Manager

Number of Participants Completing the Trial (Exercise Capacity Addendum)

Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)

Peak Exercise Cardiac Output (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study.

Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study.

Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study.

Left Ventricular Function (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study.

Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)

Some participants refused or failed to complete the FACT-Lym survey at 6-months.

Health-Related Quality of Life (Exercise Capacity Addendum)

6-minute Walk Distance (Exercise Capacity Addendum)

Some participants refused or failed to complete the FACT-Fatigue survey at 6-months.

Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)

Overall Study

Each participant will attend two presentations and six hands-on activities led by St. Jude faculty and research staff on topics within their expertise, such as cells and cancer, and healthy living. The pre-test will take place within 7±1 days before the program presentations and before students receive copies of the printed material. Two post-tests will take place. The first post-test will be administered within 7±1 days after the final scheduled program presentation and will be a measure of knowledge acquisition. The second post-test will take place 90±7 days post-intervention and will be a measure of knowledge retention.

Yuri Quintana, Ph.D

The main objectives of the study is to

* Evaluate the knowledge acquisition and retention of 4th-grade students who participate in the St. Jude Cancer Education for Children Program
* To examine the relationship between outcome measures (knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender
* To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement

The subjects in this research study will be current 4th-grade students at elementary schools in Memphis, Tennessee who choose to participate in the Program. These participants are not patients of St. Jude Children's Research Hospital. The Program will be implemented over a three-day period. Each student will attend two presentations and six hands-on activities led by St. Jude faculty and research staff on topics within their expertise, such as cells and cancer, and healthy living. Printed materials to be distributed as part of the St. Jude Cancer Education for Children Program have been developed by a multi-disciplinary team of St. Jude employees and local educators and reviewed by national experts for scientific accuracy and appropriate readability. Material includes three illustrated children's books, a laboratory manual, and activity sheets.

One pre- and two post-tests will be administered by designated school teachers. The tests consist of 10 multiple-choice questions per each of three modules(cells, cancer, and healthy living), validated by a group of experts for readability and content relevance. Knowledge acquisition will be assessed by taking the differences from first post-test to pre-test scores, obtained from 10 questions on each component of the intervention, and using one-sample signed rank test to evaluate the improvement in the knowledge scores. A similar analysis will be undertaken by taking the differences from the 2nd post-evaluation to the 1st post-evaluation for each participant to assess knowledge retention.

St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level

Knowledge acquisition will be assessed by taking the differences from first post-test to pre-test scores, obtained from 10 questions on each component of the intervention. A similar analysis will be undertaken by taking the differences from the 2nd post-evaluation to the 1st post-evaluation for each participant to assess knowledge retention.

The study will examine the relationship between outcome measures(knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender.

To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum	NCT01719562	Cardiac Toxicit... Malignant Neopl... Breast Cancer	Magnetic resona... Physical Activi... Healthy Living Cardiopulmonary... Questionnaire A...	18 Years - 85 Years	Wake Forest University Health Sciences
St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level	NCT01185093	Cancer		-	St. Jude Children's Research Hospital
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum	NCT01719562	Cardiac Toxicit... Malignant Neopl... Breast Cancer	Magnetic resona... Physical Activi... Healthy Living Cardiopulmonary... Questionnaire A...	18 Years - 85 Years	Wake Forest University Health Sciences

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