COPD Care Pathway Among Patients With Cancer

User-Centered Design of a COPD Care Pathway for Patients With Cancer

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Chronic Obstructive Pulmonary Disease; Lung Cancer
• Intervention / Treatment: Other: Observational Phase 1; Other: Observational Phase 2, Group I; Other: Observational Phase 2, Group II; Other: Observational Phase 3

Detailed Description

Primary Objective: To design a feasible 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.

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.

• Study Type: Observational
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• The participant has personal experience with medical management of COPD, defined as meeting at least one of the following 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.

Exclusion Criteria: Severe psychiatric symptoms; unusual social situation; or critical instability that would limit adherence to the study requirements, as determined by the study team.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Phase 1; Participants complete surveys	Other: Observational Phase 1; Noninterventional study
Observational Phase 2, Group I; Participants complete an interview and participate in a focus group on study.	Other: 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.	Other: 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.	Other: Observational Phase 3; Noninterventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Burdens Identified	Treatment burdens of COPD and cancer as comorbidities will be measured by self-report from patients and providers using surveys, interviews, and guided tours from at least one timepoint, with follow-up data collected from some participants up to four months later. The options for the multiple-choice survey questions are based on historical data reporting the following specific features of COPD among patients without cancer: (i) inconsistent knowledge of the diagnosis of COPD,22 (ii) negative connotations of the diagnosis of COPD upon identity, (iii) lack of confidence in the capability of treating COPD, (iv) variable confidence in the skill of self-administering an inhaler, (v) inconsistent behavioral regulation for self-management of COPD, (vi) a goal to consolidate care to fewer appointments, (vii) lack of optimism for the ability to effectively treat COPD for positive consequences, and (viii) intention to utilize expanded access to COPD care.	Up to 4 months
Number of Barriers to COPD Care in Oncology Clinics	Barriers to COPD care in the oncology clinic will be measured by self-report from patients and providers using surveys, interviews, and guided tours from at least one timepoint, with follow-up data collected from some participants up to four months later A quantitative analysis of barriers to COPD care using the data from multiple-choice survey answers of patients and providers to identify which types of barriers are most commonly experienced. The options for the multiple-choice survey questions are based on historical data reporting the following barriers to COPD care among patients without cancer: (i) inadequate information for providers or (ii) patients, (iii) lack of time, (iv) patients having a lack of faith in providers, (v) medical advice that conflicts with patients' perceptions, (vi) a desire for personal responsibility, and (vii) prohibitive cost of COPD care.	Up to 4 months
Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients	For implementation by a novel care pathway at community oncology clinics will be measured by qualitative and quantitative data collected from oncology patients and providers from at least one timepoint, with follow-up data collected from some participants up to four months later. Important and feasible components of COPD care for implementation by a novel care pathway at community oncology clinics will be measured by qualitative and quantitative data collected from oncology patients and providers from at least one timepoint, with follow-up data collected from some participants. Participants will integrate this data using a concept mapping exercise to sort and rank items to identify COPD best practices among patients with cancer.	Up to 4 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Thomas Lycan, MD, Wake Forest Baptist Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Actual): March 25, 2026
• Study Completion (Actual): March 25, 2026

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: IRB00120161; P30CA012197 (U.S. NIH Grant/Contract); ONC-LUN-2406 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center); K12TR004931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No