Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT02786628
The primary objective of this study is to assess the feasibility of a multi-institutional study that collects cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient generated health data (wearable activity monitors and patient reported outcomes) for the subsequent month. In addition to demonstrating feasibility, the study looks to generate preliminary data that supports the capacity of physical performance testing and patient-generated health data to complement clinician-rated performance status in patients receiving chemotherapy.
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Notify Me18 year and older
All sexes
Observational
Chapel Hill, North Carolina, 27514, United States
Physical fitness, based on tests of physical performance and measurements of daily activity, can serve as both a risk stratification variable and clinical outcome for patients prior to or during cytotoxic chemotherapy. Many cytotoxic therapies cause premature aging and frailty in a sizable portion of patients, so measuring and improving physical function may also limit late morbidity and mortality in certain patient populations. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) in addition to organ-specific function have been used to prognosticate risk and determine treatment strategy, but cPS only readily identifies individuals with significant functional compromise. Objective evaluations of physical function, such as aerobic capacity and measured daily activity, may have greater potential to improve the precision of performance status evaluation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will complete cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant) and wear a Fitbit Charge HR for the duration of one cycle of chemotherapy.
Time frame: 7 months
This is measure 1 for determining study feasibility
Time frame: 7 months
This is measure 2 for determining study feasibility
Time frame: 7 months
This is measure 3 for determining study feasibility
Time frame: 7 months
This is measure 4 for determining study feasibility; using UNC PRO-Core and Fitabase to collect information
Time frame: 7 months
Comparison made to determine if pre-treatment aerobic capacity is predictive of post-treatment steps per day.
Time frame: 7 months
Comparison made to determine which pre-treatment value better predicts post-treatment steps per days.
Time frame: 7 months
Time frame: 7 months
Time frame: 7 months
Time frame: 7 months
UNC Lineberger Comprehensive Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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