Back to resultsImproving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
Primary Purpose
Hodgkin Lymphoma, Non-hodgkin Lymphoma, Lymphoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Intervention (PAI)
Healthy Living Control
Sponsored by
About this trial
This is an interventional other trial for Hodgkin Lymphoma focused on measuring Physical Activity Intervention, Healthy Living Intervention, Health-related Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Subjects age 18-85 years old
- Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).
Exclusion Criteria:
- Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- A recent history of alcohol or drug abuse
- Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
- Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
Sites / Locations
- Virginia Commonwealth University Massey Cancer Center
- Virginia Commonwealth University Community Memorial Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Physical Activity Intervention (PAI)
Healthy Living Control Group
Arm Description
Tailored multi-level physical activity intervention (PAI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
Healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
Outcomes
Primary Outcome Measures
Assessment of Patient Interest in Protocol
Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
Assessment of Patient Compliance
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
Assessment of Patient Response to Interventions
Examination of qualitative data to evaluate positive and negative influences on adherence and to refine the intervention for a future large scale utilizing recorded interviews with each of the accrued subjects.
Secondary Outcome Measures
Assessment of Cardiac Output
Assessment of the subject's peak exercise cardiac output at the initial visit, then at 3 and 6 months after starting Anthracycline-based Chemotherapy (Anth-bC) utilizing Magnetic Resonance Imaging (MRI) variables, and Cardiopulmonary Exercise Testing (CPET).
Assessment of Oxygen Output
Assessment of oxygen output will be determined by using measurements from maximal oxygen intake, and a six-minute walk test to obtain exercise capacity.
Assessment of Health Related Quality of Life
Health related quality of life will be measured using the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire to assess disease-specific health related quality of life (HRQoL). The FACT-Lym scale measures HRQoL using a forty-two question assessment that measures physical well-being, social well-being, and emotional well-being. Each item on the FACT-Lym scale is scored from 0 (Not at all) to 4 (very much). All items are summed to create a total score (range 0-108) and sub-scales may be scored separately for questions related to physical well-being (range 0-28), social well-being (range 0-28), emotional well-being (range 0-24), functional well-being (range 0-28), and for lymphoma specific additional concerns (range 0-60). Negatively worded items are reverse scored prior to summing so that higher sub-scale and total scores indicate better QoL.
Assessment of Fatigue
Fatigue will be assessed by utilizing the Functional Assessment of Cancer Therapy-Fatigue scale (FACT-fatigue) assess fatigue. The FACT-fatigue scale assesses cancer related fatigue using a thirteen question scale. Each item on the FACT-Fatigue scale is scored from 0 (not at all) to 4 (very much). All items on the scale are summed to provide a total score for fatigue (range 0-52)
Assessment of General Health
The MOS 36-item Short Form Health Survey (SF-36) will also be used to to measure subject's general health. All items on the SF-36 are scored from 1 (excellent) to 5 (poor). Scores are calculated for eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
All items are scored so that a high score defines a more favorable health state. each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Assessment for Anemia
Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
Assessment of Renal Function
Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Full Information
NCT ID
NCT03923504
First Posted
April 16, 2019
Last Updated
March 3, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03923504
Brief Title
Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
Official Title
Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.
Detailed Description
This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non-hodgkin Lymphoma, Lymphoma, Breast Cancer
Keywords
Physical Activity Intervention, Healthy Living Intervention, Health-related Quality of Life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity Intervention (PAI)
Arm Type
Active Comparator
Arm Description
Tailored multi-level physical activity intervention (PAI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
Arm Title
Healthy Living Control Group
Arm Type
Active Comparator
Arm Description
Healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
Intervention Type
Other
Intervention Name(s)
Physical Activity Intervention (PAI)
Intervention Description
Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 & 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home.
Intervention Type
Other
Intervention Name(s)
Healthy Living Control
Intervention Description
Patients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible.
Primary Outcome Measure Information:
Title
Assessment of Patient Interest in Protocol
Description
Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
Time Frame
6 Months
Title
Assessment of Patient Compliance
Description
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
Time Frame
6 Months
Title
Assessment of Patient Response to Interventions
Description
Examination of qualitative data to evaluate positive and negative influences on adherence and to refine the intervention for a future large scale utilizing recorded interviews with each of the accrued subjects.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Assessment of Cardiac Output
Description
Assessment of the subject's peak exercise cardiac output at the initial visit, then at 3 and 6 months after starting Anthracycline-based Chemotherapy (Anth-bC) utilizing Magnetic Resonance Imaging (MRI) variables, and Cardiopulmonary Exercise Testing (CPET).
Time Frame
6 Months
Title
Assessment of Oxygen Output
Description
Assessment of oxygen output will be determined by using measurements from maximal oxygen intake, and a six-minute walk test to obtain exercise capacity.
Time Frame
6 Months
Title
Assessment of Health Related Quality of Life
Description
Health related quality of life will be measured using the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire to assess disease-specific health related quality of life (HRQoL). The FACT-Lym scale measures HRQoL using a forty-two question assessment that measures physical well-being, social well-being, and emotional well-being. Each item on the FACT-Lym scale is scored from 0 (Not at all) to 4 (very much). All items are summed to create a total score (range 0-108) and sub-scales may be scored separately for questions related to physical well-being (range 0-28), social well-being (range 0-28), emotional well-being (range 0-24), functional well-being (range 0-28), and for lymphoma specific additional concerns (range 0-60). Negatively worded items are reverse scored prior to summing so that higher sub-scale and total scores indicate better QoL.
Time Frame
6 Months
Title
Assessment of Fatigue
Description
Fatigue will be assessed by utilizing the Functional Assessment of Cancer Therapy-Fatigue scale (FACT-fatigue) assess fatigue. The FACT-fatigue scale assesses cancer related fatigue using a thirteen question scale. Each item on the FACT-Fatigue scale is scored from 0 (not at all) to 4 (very much). All items on the scale are summed to provide a total score for fatigue (range 0-52)
Time Frame
6 Months
Title
Assessment of General Health
Description
The MOS 36-item Short Form Health Survey (SF-36) will also be used to to measure subject's general health. All items on the SF-36 are scored from 1 (excellent) to 5 (poor). Scores are calculated for eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
All items are scored so that a high score defines a more favorable health state. each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time Frame
6 Months
Title
Assessment for Anemia
Description
Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
Time Frame
6 Months
Title
Assessment of Renal Function
Description
Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects age 18-85 years old
Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).
Exclusion Criteria:
Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
A recent history of alcohol or drug abuse
Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Lucas, Ph.D.
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University Community Memorial Health Center
City
South Hill
State/Province
Virginia
ZIP/Postal Code
23970
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT01719562?term=NCT01719562&draw=2&rank=1
Description
NCT01719562: MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Learn more about this trial
Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
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