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出境医 / 临床实验 / Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx

Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx

Study Description
Brief Summary:
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Non-hodgkin Lymphoma Lymphoma Breast Cancer Other: Physical Activity Intervention (PAI) Other: Healthy Living Control Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Physical Activity Intervention (PAI)
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).
Other: Physical Activity Intervention (PAI)
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.

Active Comparator: Healthy Living Control Group
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).
Other: Healthy Living Control
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.

Outcome Measures
Primary Outcome Measures :
  1. Assessment of Patient Interest in Protocol [ Time Frame: 6 Months ]
    Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.

  2. Assessment of Patient Compliance [ Time Frame: 6 Months ]
    Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.

  3. Assessment of Patient Response to Interventions [ Time Frame: 6 Months ]
    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 :
  1. Assessment of Cardiac Output [ Time Frame: 6 Months ]
    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).

  2. Assessment of Oxygen Output [ Time Frame: 6 Months ]
    Assessment of oxygen output will be determined by using measurements from maximal oxygen intake, and a six-minute walk test to obtain exercise capacity.

  3. Assessment of Health Related Quality of Life [ Time Frame: 6 Months ]
    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.

  4. Assessment of Fatigue [ Time Frame: 6 Months ]
    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)

  5. Assessment of General Health [ Time Frame: 6 Months ]

    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.


  6. Assessment for Anemia [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.

  7. Assessment of Renal Function [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess for renal (kidney) dysfunction


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Rebecca Maggi, RN (804)827-1025 MCCCardioonc@vcu.edu
Contact: Alexander Lucas, Ph.D. (804)827-1025 MCCCardioonc@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Alexander Lucas, PhD    804-628-6610    Alexander.Lucas@vcuhealth.org   
Virginia Commonwealth University Community Memorial Health Center Not yet recruiting
South Hill, Virginia, United States, 23970
Contact: Lucas R Alexander, PhD       Alexander.Lucas@vcuhealth.org   
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
Principal Investigator: Alexander Lucas, Ph.D. Massey Cancer Center
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Assessment of Patient Interest in Protocol [ Time Frame: 6 Months ]
    Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
  • Assessment of Patient Compliance [ Time Frame: 6 Months ]
    Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
  • Assessment of Patient Response to Interventions [ Time Frame: 6 Months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Assessment of Cardiac Output [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
  • Assessment of Renal Function [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Assessment of Cardiac Output [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    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 [ Time Frame: 6 Months ]
    Health related quality of life will be measured using fatigue and health-related quality of life questionnaires.
  • Assessment for Anemia [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
  • Assessment of Renal Function [ Time Frame: 6 Months ]
    Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
Official Title  ICMJE Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Hodgkin Lymphoma
  • Non-hodgkin Lymphoma
  • Lymphoma
  • Breast Cancer
Intervention  ICMJE
  • Other: Physical Activity Intervention (PAI)
    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.
  • Other: Healthy Living Control
    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.
Study Arms  ICMJE
  • Active Comparator: Physical Activity Intervention (PAI)
    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).
    Intervention: Other: Physical Activity Intervention (PAI)
  • Active Comparator: Healthy Living Control Group
    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: Other: Healthy Living Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
15
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Maggi, RN (804)827-1025 MCCCardioonc@vcu.edu
Contact: Alexander Lucas, Ph.D. (804)827-1025 MCCCardioonc@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923504
Other Study ID Numbers  ICMJE MCC-19-14621
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Lucas, Ph.D. Massey Cancer Center
PRS Account Virginia Commonwealth University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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