Clinical trial · Observational
Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Solid Tumour | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Planned Hematopoietic Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical performance testing and patient-generated health data | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Solid tumor malignancies
- description
- 15 patients. Will participate in physical performance testing and patient-generated health data.
- interventionNames
- Other: Physical performance testing and patient-generated health data
- label
- Hematologic malignancies
- description
- 15 patients. Will participate in physical performance testing and patient-generated health data.
- interventionNames
- Other: Physical performance testing and patient-generated health data
- label
- Hematopoietic cell transplantation
- description
- 15 patients. Will participate in physical performance testing and patient-generated health data.
- interventionNames
- Other: Physical performance testing and patient-generated health data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with solid tumor or hematologic malignancies who are planning to receive a cycle of cytotoxic chemotherapy or patients who are planning to receive stem cell transplant. * Age ≥ 18 * At least 6 weeks out from surgical resection * Presence of working email address * Access to internet at home and access to electronic device(s) capable of charging and syncing the Fitbit * Ability to read and understand English * Ability to understand and comply with study procedures including wearing Fitbit for the entire length of the study * Approval of attending oncologist for participation in the study * Hb ≥ 8 g/dL (most recent lab draw) * Willingness and ability to provide written informed consent Exclusion Criteria: * Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent * Presence of cardiac disease including acute MI within past 6 weeks, unstable angina, uncontrolled arrhythmias causing symptoms, active endocarditis, myocarditis, or pericarditis,symptomatic aortic stenosis, uncontrolled heart failure, syncope in the past 6 weeks, severe untreated hypertension at rest (\>180 mmHg systolic, \>100 mmHg diastolic) * Acute pulmonary embolism or thrombosis of lower extremities in the past 6 weeks * Uncontrolled asthma * Pulmonary edema * Suspected dissecting aneurysm * Room air desaturation at rest \</= 88% * Respiratory failure * Acute noncardiopulmonary disorder that may be aggravated by exercise * Mental impairment leading to inability to cooperate with instructions * Orthopedic impairment that compromises exercise performance
References
Publications (1)
- DERIVEDWood 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. PMID 36812616