Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
1 other identifier
interventional
12
1 country
2
Brief Summary
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2022
CompletedMarch 7, 2023
March 1, 2023
2.9 years
April 16, 2019
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
6 Months
Assessment of Patient Compliance
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
6 Months
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.
6 Months
Secondary Outcomes (7)
Assessment of Cardiac Output
6 Months
Assessment of Oxygen Output
6 Months
Assessment of Health Related Quality of Life
6 Months
Assessment of Fatigue
6 Months
Assessment of General Health
6 Months
- +2 more secondary outcomes
Study Arms (2)
Physical Activity Intervention (PAI)
ACTIVE COMPARATORTailored 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 Control Group
ACTIVE COMPARATORHealthy 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298, United States
Virginia Commonwealth University Community Memorial Health Center
South Hill, Virginia, 23970, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Lucas, Ph.D.
Massey Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2019
First Posted
April 22, 2019
Study Start
May 10, 2019
Primary Completion
April 18, 2022
Study Completion
April 18, 2022
Last Updated
March 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share