Chronic Obstructive Pulmonary DiseaseNCT05984680
COPD Care Pathway Among Patients With Cancer
An observational study of Chronic Obstructive Pulmonary Disease and Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Cancer, Head and Neck Cancer
- What is being tested?
- Observational Phase 1, Observational Phase 2, Group I and Observational Phase 2, Group II
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 25 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Being tested
- Observational Phase 1, Observational Phase 2, Group I, Observational Phase 2, Group II, Observational Phase 3
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Phase 1Other
Noninterventional study
Observational Phase 2, Group IOther
Noninterventional study
Observational Phase 2, Group IIOther
Noninterventional study
Observational Phase 3Other
Noninterventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational Phase 1 | Participants complete surveys Receives: Other: Observational Phase 1 | |
| Observational Phase 2, Group I | Participants complete an interview and participate in a focus group on study. Receives: 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. Receives: 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. Receives: Other: Observational Phase 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start27 Feb 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Thomas Lycan, MD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984680
- Sponsor's protocol ID
- IRB00120161
- Other IDs
- P30CA012197, ONC-LUN-2406, K12TR004931
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41084760
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-Centered Design of a COPD Care Pathway for Patients With Cancer
- ClinicalTrials.gov ID
- NCT05984680
- Acronym / sponsor ID
- IRB00120161
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observational Phase 1 | – | Other: Observational Phase 1Participants complete surveys |
| Observational Phase 2, Group I | – | Other: Observational Phase 2, Group IParticipants complete an interview and participate in a focus group on study. |
| Observational Phase 2, Group II | – | Other: Observational Phase 2, Group IIParticipants complete an interview and participate in guided tours of the oncology clinic on study. |
| Observational Phase 3 | – | Other: Observational Phase 3A subset of interested participants from Phase 2 participate in a workshop on study to develop a final draft of the COPD care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- The participant has personal experience with medical management of COPD, defined as meeting at least one of the following criteria:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Phase 1Noninterventional study | Other | Observational Phase 1 |
| Observational Phase 2, Group INoninterventional study | Other | Observational Phase 2, Group I |
| Observational Phase 2, Group IINoninterventional study | Other | Observational Phase 2, Group II |
| Observational Phase 3Noninterventional study | Other | Observational Phase 3 |
Primary outcome
Feasibility of Designing a Novel COPD Care Pathway
Time frame: Up to 60 days
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.
3 secondary outcomes
Number of Treatment Burdens Identified
Time frame: Up to 4 months
Number of Barriers to COPD Care in Oncology Clinics
Time frame: Up to 4 months
Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients
Time frame: Up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 41084760Lycan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lycan, MD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Designing a Novel COPD Care Pathway (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.