Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
Summary
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.
Arms & interventions
- OtherCardio-oncology program
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)
Outcome measures
Primary
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
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).
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
Secondary
Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.
Time frame: 8 weeks post enrollment
Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program
Time frame: 8 weeks post enrollment
Difference in biomarkers after an 8-week cardio-oncology prehabilitation program
Time frame: 8 weeks post enrollment
Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program
Time frame: 8 weeks post enrollment
Eligibility criteria
Study locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109