Acute Myeloid Leukemia
Conditions
Brief summary
This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a "prehabilitation" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.
Detailed description
OUTLINE: Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study. After completion of the study intervention, patients are followed for 12 months.
Interventions
OTHERAerobic Exercise
Undergo moderate-intensity aerobic exercises
OTHERResistance Training
Undergo strength training
PROCEDUREBiospecimen Collection
Undergo collection of blood
OTHERElectronic Health Record Review
Ancillary studies
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
University of Washington
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Ability to understand and willingness to sign a written informed consent document * New diagnosis of acute myeloid leukemia at Fred Hutch * High-risk patients as defined by one, or more, of the following criteria: * Age 65 years or older and/or * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and/or * CARE-BMT score ≥ 5 * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff * Able to exercise at low to moderate intensity, as evaluated by study staff * Access to a mobile smart phone * Able to read and write in English
Exclusion criteria
* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility * Recurrence of AML or diagnosis of other invasive cancer * Severe anemia (hemoglobin \< 7 gm/dl) * History of severe aortic stenosis * New York Heart Association (NYHA) class IV heart failure * Severe pain with basic movement * Pregnant persons * Unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates (Feasibility) | Up to 24 months | Recruitment will be calculated as the proportion of eligible patients who provide informed consent, with 95% confidence intervals, and reasons for ineligibility or refusal summarized from screening logs. |
| Retention rates (Feasibility) | Up to 24 months | Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals. |
| Adherence to program (Feasibility) | At the end of the CAREFit-BMT program (Day 85) | Adherence will be evaluated from both aerobic and resistance training participation, including the percentage of prescribed sessions completed and average weekly minutes of moderate-intensity aerobic activity from wearable device data. |
| Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score | At the end of the CAREFit-BMT program (Day 85) | Acceptability will be assessed using validated instrument, Acceptability of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater acceptability. |
| Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score | At the end of the CAREFit-BMT program (Day 85) | Will be assessed using validated instrument, Intervention Appropriateness Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater appropriateness. |
| Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score | At the end of the CAREFit-BMT program (Day 85) | Will be assessed using validated instrument, Feasibility of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) | At the end of the CAREFit-BMT program (Day 85) | Participant-specific barriers and facilitators to enrollment, participation, and adherence, will be assessed through semi-structured qualitative interviews informed by the Capability, Opportunity, Motivation, and Behavior (COM-B) framework. |
| Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured by cardiopulmonary exercise testing to assess anaerobic threshold. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
| Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak) | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured by cardiopulmonary exercise testing to assess peak oxygen consumption (VO₂peak). Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
| Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured by cardiopulmonary exercise testing to assess VO₂peak percent-predicted. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
| Changes in cardiorespiratory fitness (CRF): Mean change in Respiratory exchange ratio at peak | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured by cardiopulmonary exercise testing to assess respiratory exchange ratio at peak. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
| Changes in cardiorespiratory fitness (CRF): Mean change in Minute ventilation/carbon dioxide production (VE/VCO₂) slope | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured by cardiopulmonary exercise testing to assess minute ventilation/carbon dioxide production (VE/VCO₂) slope. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
| Changes in cardiovascular (CV) symptoms | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be measured using the Kansas City Cardiomyopathy Questionnaire-12. Standardized scores range from 0-100, with higher scores indicating better outcome. |
| Changes in CV biomarkers | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will include cardiac troponins (I \& T), NT-pro-BNP, and IL-6 measured in collected blood samples through University of Washington Research Testing Service. |
| Changes in quality of life | Baseline up to the end of the CAREFit-BMT program (Day 85) | Will be assessed using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire. Total scores range from 0-148, with higher scores indicating better outcome. |
Countries
United States
Contacts
CONTACTAlexi Vasbinder, PhD, RN
PRINCIPAL_INVESTIGATORAlexi Vasbinder, PhD, RN
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed