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

• ClinicalTrials.gov Identifier: NCT05945121
• Recruitment Status: Recruiting
• First Posted: July 14, 2023
• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Institutes of Health (NIH); National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Michigan Rogel Cancer Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hematopoietic Stem Cell Transplant	Other: Cardio-oncology program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: August 25, 2023
• Estimated Primary Completion Date: August 2027
• Estimated Study Completion Date: August 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cardio-oncology program; 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; 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 Outcome Measures :

1. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate). [ Time Frame: 8 weeks post enrollment ]
   Percent of eligible participants who are screened and give informed consent
2. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates). [ Time Frame: 8 weeks post enrollment ]
   percentage of enrolled participants who complete pre-post CV assessments
3. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment). [ Time Frame: 8 weeks post enrollment ]
   the number of participants recruited per month
4. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol). [ Time Frame: 8 weeks post enrollment ]
   the average amount of time required for participants to complete initial and follow-up CV assessments
5. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days). [ Time Frame: 8 weeks post enrollment ]
   The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.
6. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time). [ Time Frame: 8 weeks post enrollment ]
   The average duration (min) of aerobic and resistance workouts over the course of the intervention.
7. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data). [ Time Frame: 8 weeks post enrollment ]
   the percentage of missing data from study questionnaires.
8. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction). [ Time Frame: 8 weeks post enrollment ]
   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
9. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold). [ Time Frame: 8 weeks post enrollment ]
   change in anaerobic threshold from pre to post intervention reported in L/min
10. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak). [ Time Frame: 8 weeks post enrollment ]
    change in VO2peak from pre to post intervention reported in ml/kg/min
11. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted). [ Time Frame: 8 weeks post enrollment ]
    Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values
12. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER). [ Time Frame: 8 weeks post enrollment ]
    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
13. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope). [ Time Frame: 8 weeks post enrollment ]
    Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention

Secondary Outcome Measures :

1. Symptom assessment scores after an 8-week cardio-oncology prehabilitation program. [ Time Frame: 8 weeks post enrollment ]
   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.
2. Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program [ Time Frame: 8 weeks post enrollment ]
   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.
3. Difference in biomarkers after an 8-week cardio-oncology prehabilitation program [ Time Frame: 8 weeks post enrollment ]
   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.
4. Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program [ Time Frame: 8 weeks post enrollment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• Ability to understand and the willingness to sign a written informed consent
• Ability to use Polar Flow heart rate application

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.

Contacts and Locations

Contacts

Contact: Cancer AnswerLine; 1-800-865-1125; CancerAnswerLine@med.umich.edu

Locations

United States, Michigan

University of Michigan Rogel Cancer Center; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Cancer AnswerLine 800-865-1125 CancerAnswerLine@med.umich.edu

Principal Investigator: Salim Hayek

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Salim Hayek; University of Michigan Rogel Cancer Center

More Information

• Responsible Party: University of Michigan Rogel Cancer Center
• ClinicalTrials.gov Identifier: NCT05945121
• Other Study ID Numbers: UMCC 2023.004; HUM00223835 ( Other Identifier: University of Michigan ); U24HL157560 ( U.S. NIH Grant/Contract )
• First Posted: July 14, 2023
• Last Update Posted: May 1, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Michigan Rogel Cancer Center:

Cardiovascular disease