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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid tumor malignancies | 15 patients. Will participate in physical performance testing and patient-generated health data. |
| |
| Hematologic malignancies | 15 patients. Will participate in physical performance testing and patient-generated health data. |
| |
| Hematopoietic cell transplantation | 15 patients. Will participate in physical performance testing and patient-generated health data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical performance testing and patient-generated health data | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients being approached that agree to participate in the study | This is measure 1 for determining study feasibility | 7 months |
| Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events | This is measure 2 for determining study feasibility | 7 months |
| Proportion of recruited patients who wear Fitbit for at least 8 hours per day | This is measure 3 for determining study feasibility | 7 months |
| Proportion of patients for whom all data is successfully recorded within database | This is measure 4 for determining study feasibility; using UNC PRO-Core and Fitabase to collect information | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day | Comparison made to determine if pre-treatment aerobic capacity is predictive of post-treatment steps per day. | 7 months |
| Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day |
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Inclusion Criteria:
Exclusion Criteria:
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45 patients with cancer undergoing a cycle of cytotoxic chemotherapy or bone marrow transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Grover, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| William A Wood, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36812616 | Derived | Wood WA, Dilip D, Derkach A, Grover NS, Elemento O, Levine R, Thanarajasingam G, Batsis JA, Bailey C, Kannappan A, Devine SM, Artz AS, Ligibel JA, Basch E, Kent E, Glass J. Wearable sensor-based performance status assessment in cancer: A pilot multicenter study from the Alliance for Clinical Trials in Oncology (A19_Pilot2). PLOS Digit Health. 2023 Jan 26;2(1):e0000178. doi: 10.1371/journal.pdig.0000178. eCollection 2023 Jan. |
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|
Comparison made to determine which pre-treatment value better predicts post-treatment steps per days. |
| 7 months |
| Compare pre-treatment aerobic capacity (VO2max or 6MWD) and post-treatment average measured steps per day among the three cohorts (solid tumor, hematologic malignancies, hematopoietic cell transplantation) | 7 months |
| Compare average measured steps per day and patient-reported symptomatic toxicities | 7 months |
| Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy | 7 months |
| Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit | 7 months |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D000076206 | Patient Generated Health Data |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D055991 | Health Records, Personal |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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