Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
1 other identifier
observational
11
1 country
1
Brief Summary
The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedApril 16, 2020
April 1, 2020
4.4 years
November 4, 2015
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VO2peak
is a measure determined by the CPET
1 year
Study Arms (1)
functional performance testing
This observational study will evaluate the feasibility and safety of functional performance testing in patients undergoing HCT. In addition to standard of care procedures, participants will undergo a CPET with a rest and stress echo, pulmonary function, and patient reported outcome questionnaires within 30 days of HCT.
Interventions
Eligibility Criteria
Potentially eligible will be identified through and recruited from the Adult Bone Marrow Transplantation clinics at MSK.
You may qualify if:
- Patients with MSK histologically confirmed hematologic malignancy
- Scheduled for autologous or allogenic HCT at MSKCC
- ≥21 years old
- ECOG performance status of 0 or 1
- Completion of baseline CPET
- Willing to comply with protocol related procedures
You may not qualify if:
- Any of the following absolute contraindications to cardiopulmonary exercise testing
- Acute myocardial Infarction (within 3-5 days of any planned study procedures)
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 6, 2015
Study Start
November 1, 2015
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
April 16, 2020
Record last verified: 2020-04