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Clinical Trials/NCT05984680
NCT05984680CompletedNot Applicable

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

Wake Forest University Health Sciences1 site in 1 country101 target enrollmentStarted: February 27, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
101
Locations
1
Primary Endpoint
Feasibility of Designing a Novel COPD Care Pathway

Study Overview

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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Arms & Interventions

Observational Phase 1

Participants complete surveys

Intervention: Observational Phase 1 (Other)

Observational Phase 2, Group I

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

Intervention: Observational Phase 2, Group I (Other)

Observational Phase 2, Group II

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

Intervention: Observational Phase 2, Group II (Other)

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.

Intervention: Observational Phase 3 (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients(Up to 4 months)
  • Number of Treatment Burdens Identified(Up to 4 months)
  • Number of Barriers to COPD Care in Oncology Clinics(Up to 4 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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