Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
- Conditions
- Hodgkin LymphomaNon-hodgkin LymphomaLymphomaBreast Cancer
- Interventions
- Other: Physical Activity Intervention (PAI)Other: Healthy Living Control
- Registration Number
- NCT03923504
- Lead Sponsor
- Virginia Commonwealth University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Activity Intervention (PAI) 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). Healthy Living Control Group Healthy Living Control 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).
- Primary Outcome Measures
Name Time Method Assessment of Patient Interest in Protocol 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 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 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
Name Time Method Assessment of Oxygen Output 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 Cardiac Output 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 Health Related Quality of Life 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 Renal Function 6 Months Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Assessment for Anemia 6 Months Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
Assessment of Fatigue 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 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.
Trial Locations
- Locations (2)
Virginia Commonwealth University Community Memorial Health Center
🇺🇸South Hill, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States