COPD Care Pathway Among Patients With Cancer

NCT ID: NCT05984680

Last Updated: 2026-01-21

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-27

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Lung Cancer Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Phase 1

Participants complete surveys

Observational Phase 1

Intervention Type OTHER

Noninterventional study

Observational Phase 2, Group I

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

Observational Phase 2, Group I

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Noninterventional study

Interventions

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Observational Phase 1

Noninterventional study

Intervention Type OTHER

Observational Phase 2, Group I

Noninterventional study

Intervention Type OTHER

Observational Phase 2, Group II

Noninterventional study

Intervention Type OTHER

Observational Phase 3

Noninterventional study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 41084760 (View on PubMed)

Other Identifiers

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P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ONC-LUN-2406

Identifier Type: OTHER

Identifier Source: secondary_id

K12TR004931

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00120161

Identifier Type: -

Identifier Source: org_study_id

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