Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

Conditions
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Hematopoietic Stem Cell Transplant

Intervention / Treatment
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* Other: Cardio-oncology program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years or older Referred for CV evaluation prior to HSCT Able to ambulate unassisted Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 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 Gross balance deficits Severe pain with basic movement Unable to ambulate unassisted or exercise NYHA class IV heart failure Adults unable to give consent, pregnant women, and prisoners are excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardio-oncology program<br>The cardio-oncology program consists of a multimodal approach, which includes individualized exercise prescription following a detailed CV assessment and medical management of CV risk factors occurring over 8 weeks. | Other: Cardio-oncology program<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 8 weeks post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 8 weeks post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease