Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2025-02-27
2026-03-31
Brief Summary
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Detailed Description
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Secondary Objectives:
* To identify, characterize, and explain the treatment burdens of COPD and cancer as comorbidities, as reported by patients and providers.
* To identify, characterize, and explain barriers to COPD care in the oncology clinic, as reported by patients and providers.
* To identify, characterize, and explain important and feasible components of COPD care for patients with cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational Phase 1
Participants complete surveys
Observational Phase 1
Noninterventional study
Observational Phase 2, Group I
Participants complete an interview and participate in a focus group on study.
Observational Phase 2, Group I
Noninterventional study
Observational Phase 2, Group II
Participants complete an interview and participate in guided tours of the oncology clinic on study.
Observational Phase 2, Group II
Noninterventional study
Observational Phase 3
A subset of interested participants from Phase 2 participate in a workshop on study to develop a final draft of the COPD care pathway.
Observational Phase 3
Noninterventional study
Interventions
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Observational Phase 1
Noninterventional study
Observational Phase 2, Group I
Noninterventional study
Observational Phase 2, Group II
Noninterventional study
Observational Phase 3
Noninterventional study
Eligibility Criteria
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Inclusion Criteria
1. patient with clinical documentation of COPD (either as a confirmed or suspected diagnosis) and has received at least one dose of an immune checkpoint inhibitor for cancer or
2. provider who currently works at least part-time in a medical oncology clinic or
3. provider who works at least part-time to care for patients with known or suspected COPD.
A suspected diagnosis of COPD can be based on finding(s) by history, exam, or radiography (e.g., CT changes such as emphysema, bronchial wall thickening, or mucus plugging). A provider is defined as a physician, advanced practice provider, nurse, or respiratory therapist. Study team members are permitted to participate in the study if they meet eligibility criteria.
* Ability to understand and agree to participate on the study as described by the study information sheet.
* Capability of speaking or reading English.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Thomas Lycan, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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References
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Lycan TW Jr, Price SN, Mileham K, Stoen E, Ruiz J, Ohar JA, Norton D, Koch AL, Petty WJ, Birken SA. User-centered design of a COPD care pathway for patients with cancer: a mixed-methods clinical trial protocol. Future Oncol. 2025 Oct;21(25):3259-3273. doi: 10.1080/14796694.2025.2562715. Epub 2025 Oct 14.
Other Identifiers
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