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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01613 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 99112 | Other Identifier | Wake Forest University Health Sciences | |
| R01CA167821 | U.S. NIH Grant/Contract | View source | |
| R21CA226960 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADDENDUM: Physical Activity Intervention | Experimental | 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. |
|
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | Experimental | 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. . |
|
| MRI (Diagnostic) | Experimental | Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging | Procedure | Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing the Trial (Exercise Capacity Addendum) | The number of participants who completed the intervention. | 6 months after treatment initiation |
| Number of Participants Able to Complete Assessments (Exercise Capacity Addendum) | Number of participants who completed the 6-minute walk test at 6-months. | 6 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Exercise Cardiac Output (Exercise Capacity Addendum) | 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. | 6 months after treatment |
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PARENT STUDY:
Inclusion Criteria:
Exclusion Criteria:
EXERCISE CAPACITY ADDENDUM:
Inclusion Criteria:
Exclusion Criteria: The following are relative contraindications and can be considered by the medical director of the study:
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| Name | Affiliation | Role |
|---|---|---|
| William Hundley | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41877348 | Derived | Leitzelar BN, Costa JV, Aguilar AA, Wolle BR, Lucas AR, Marshall A, Norton S, Mihalko SL, Brubaker PH, Vaidya R, Seegars MB, Yazbeck V, Franco RL, Via J, Hundley WG, Wagner LI. Qualitative Study of Breast Cancer and Lymphoma Patients Participating in a Physical Activity Intervention: The Case for Tailored Physical Activity. Cancer Med. 2026 Mar;15(3):e71747. doi: 10.1002/cam4.71747. | |
| 39810280 | Derived | Costa JV, Lucas AR, Mihalko SL, Brubaker PH, Marshall A, Leitzelar B, Wolle BR, Norton S, Franco RL, Via J, Yazbeck V, Vaidya R, Seegars MB, D'Agostino R Jr, Wagner L, Hundley WG. Feasibility and preliminary efficacy of a physical activity intervention in adults with lymphoma undergoing treatment. Pilot Feasibility Stud. 2025 Jan 14;11(1):6. doi: 10.1186/s40814-024-01580-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADDENDUM: Physical Activity Intervention | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2021 |
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For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.
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|
| Physical Activity | Other | Tailored aerobic exercise program onsite and at home. |
|
| Healthy Living | Other | Healthy living presentations at a centralized meeting place and over the phone. |
|
| Cardiopulmonary Exercise Testing (CPET) | Device | Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level. |
|
| Questionnaire Administration | Other | A self-administered 13-item scale to assess fatigue in participants |
|
| Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Left Ventricular Function (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Health-Related Quality of Life (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| 6-minute Walk Distance (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum) | 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. | 6 months after treatment initiation |
| Virginia Commonwealth University Health Sciences |
| Richmond |
| Virginia |
| 23284 |
| United States |
| 38845066 | Derived | Mabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1. |
| 38634292 | Derived | Garg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18. |
| FG001 | ADDENDUM: Healthy Living Instruction Group (Control Arm) | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ADDENDUM: Physical Activity Intervention | 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 |
| BG001 | ADDENDUM: Healthy Living Instruction Group (Control Arm) | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing the Trial (Exercise Capacity Addendum) | The number of participants who completed the intervention. | Posted | Count of Participants | Participants | 6 months after treatment initiation |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants Able to Complete Assessments (Exercise Capacity Addendum) | Number of participants who completed the 6-minute walk test at 6-months. | Posted | Count of Participants | Participants | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||||
| Secondary | Peak Exercise Cardiac Output (Exercise Capacity Addendum) | 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. | Posted | Mean | Standard Deviation | mL/min | 6 months after treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum) | 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. | Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study. | Posted | Mean | Standard Deviation | mL/100 mL | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum) | 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. | Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study. | Posted | Mean | Standard Deviation | mL/kg/min | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Function (Exercise Capacity Addendum) | 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. | Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study. | Posted | Mean | Standard Deviation | LVEF Percentage | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||
| Secondary | Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum) | 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. | Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||
| Secondary | Health-Related Quality of Life (Exercise Capacity Addendum) | 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. | Some participants refused or failed to complete the FACT-Lym survey at 6-months. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after treatment initiation |
| ||||||||||||||||||||||||||||||
| Secondary | 6-minute Walk Distance (Exercise Capacity Addendum) | 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. | Posted | Mean | Standard Deviation | meters | 6 months after treatment initiation |
| |||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum) | 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. | Some participants refused or failed to complete the FACT-Fatigue survey at 6-months. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months after treatment initiation |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADDENDUM: Physical Activity Intervention | 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 | 1 | 20 | 0 | 20 | 1 | 20 |
| EG001 | ADDENDUM: Healthy Living Instruction Group (Control Arm) | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea due to home-based exercise session | Gastrointestinal disorders | Non-systematic Assessment | Participant experienced nausea during online kickboxing class. Recovered within 2 hours after exercise. Adjusted exercise recommendation to stay below high HR ranges. Participant completed the study. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Wake Forest University | +1(336) 758-3728 | jvolpini@wakehealth.edu |
| Mar 29, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2022 | Aug 5, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D015444 | Exercise |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-Hodgkin Lymphoma |
|
| Breast Cancer |
|
|
|
|
|
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
|
|
|
|
|
|
| OG001 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) |
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 |
|
|
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 |
|
|
|
|
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
|
|