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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Consented 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)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGFeasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
Percent of eligible participants who are screened and give informed consent
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
percentage of enrolled participants who complete pre-post CV assessments
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
the number of participants recruited per month
Time frame: 8 weeks post enrollment
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
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).
The average duration (min) of aerobic and resistance workouts over the course of the intervention.
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).
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the percentage of missing data from study questionnaires.
Time frame: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).
Assessed qualitatively with in-depth, semi-structured, one-to-one exit interviews with participants. A member of the research team experienced with telephone interviews, but not involved in intervention delivery, will contact all patients within 1 week after completion of the final follow-up assessment.The researcher will facilitate the interviews using a conversational-style approach whilst referring to a topic guide. Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the program. The researcher will additionally ask questions regarding reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients. The topic guide will be used flexibly to allow patients to raise additional issues which they consider important to the study. Interviews will be recorded with participants knowledge and then transcribed, coded, and assessed for relevant themes and recommendations using iterative thematic analysis
Time frame: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold).
change in anaerobic threshold from pre to post intervention reported in L/min
Time frame: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak).
change in VO2peak from pre to post intervention reported in ml/kg/min
Time frame: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted).
Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values
Time frame: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER).
change in RER (a ratio between cardiac dioxide output (VCO2)/oxygen uptake (VO2)) from pre to post intervention reported as the percent difference between the values
Time frame: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope).
Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention
Time frame: 8 weeks post enrollment
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.
Time frame: 8 weeks post enrollment
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.
Time frame: 8 weeks post enrollment
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.
Time frame: 8 weeks post enrollment
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.
Time frame: 8 weeks post enrollment