To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in Hematopoietic stem cell transplant (HSCT) recipients.
Adult 18 years or older
Referred for HSCT evaluation
Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes)
Able to ambulate unassisted
Severe anemia (hemoglobin <7 gm/dl)
Untreated high-risk coronary artery disease (left main, triple vessel disease)
Severe aortic stenosis
Recent fracture as assessed via self-report
Single group
Cardio-oncology program
Other interventionConsented patients will undergo an initial CV evaluation as part of standard of care then participate in an 8-week at-home, personalized exercise intervention followed by an additional CV assessment prior to HSCT (after 8-weeks)
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
Percent of eligible participants who are screened and give informed consent
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
percentage of enrolled participants who complete pre-post CV assessments
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
the number of participants recruited per month
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).
the average amount of time required for participants to complete initial and follow-up CV assessments
Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.
Frequency and severity of cardiovascular symptoms (fatigue, shortness of breath, edema) will be assessed using the short Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health. Items are grouped into the four domains; Physical limitation, Symptom frequency, Quality of life, and Social limitation.
Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program
Overall quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Responses are given on a single-item ranging in score from 0 to 100. A high scale score represents a higher response level.
Difference in biomarkers after an 8-week cardio-oncology prehabilitation program
High-sensitivity troponin-I (RayBiotech), B-type natriuretic peptide (BNP) (RayBiotech), and soluble urokinase plasminogen activator receptor (suPAR) (Virogates) will be measured in residual serum samples collected as part of usual care using enzyme-linked immunosorbent assays.
Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program
We will calculate the percentage of participants evaluated who end up being eligible for HSCT and compare rates to the number of participants who are referred to cardio-oncology, do not receive the intervention, and are considered ineligible.
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University of Michigan Rogel Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
