COPD Care Pathway Among Patients With Cancer

NCT05984680 | Completed

• 4 other identifiers: IRB00120161P30CA012197ONC-LUN-2406K12TR004931
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study gathers information for the development of a COPD care pathway for patients with cancer that reduces the treatment burden of patients, implements critical components of COPD care, and overcomes common barriers to COPD care in the community oncology clinic.

Conditions

Chronic Obstructive Pulmonary Disease; Lung Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of Designing a Novel COPD Care Pathway

  The feasibility of designing a novel COPD care pathway for patients with cancer that is responsive to mixed methods data by specifically addressing (i) the reduction of treatment burden of patients, (ii) the implementation of important and feasible components of COPD care, and (iii) the adaptation necessary to overcome common barriers to COPD care in the community oncology clinic, with feasibility defined by the agreement of a supermajority of stakeholders at a design team workshop.

  Up to 60 days

Secondary Outcomes (3)

• Number of Treatment Burdens Identified

  Up to 4 months

• Number of Barriers to COPD Care in Oncology Clinics

  Up to 4 months

• Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients

  Up to 4 months

Study Arms (4)

Observational Phase 1

Participants complete surveys

Other: Observational Phase 1

Observational Phase 2, Group I

Participants complete an interview and participate in a focus group on study.

Other: Observational Phase 2, Group I

Observational Phase 2, Group II

Participants complete an interview and participate in guided tours of the oncology clinic on study.

Other: Observational Phase 2, Group II

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.

Other: Observational Phase 3

Interventions

Observational Phase 2, Group II OTHER

Noninterventional study

Observational Phase 2, Group II

Observational Phase 1 OTHER

Noninterventional study

Observational Phase 1

Observational Phase 2, Group I OTHER

Noninterventional study

Observational Phase 2, Group I

Observational Phase 3 OTHER

Noninterventional study

Observational Phase 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with clinical documentation of COPD and has received at least one dose of an immune checkpoint inhibitor for cancer or provider who currently works at least part-time in a medical oncology clinic or to care for patients with known or suspected COPD.

You may qualify if:

• The participant has personal experience with medical management of COPD, defined as meeting at least one of the following criteria:
• 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
• provider who currently works at least part-time in a medical oncology clinic or
• 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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 41084760 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Thomas Lycan, MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: February 27, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)