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Completed

NCT Number: NCT05984680

COPD Care Pathway Among 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational Phase 1

Other

Noninterventional study

Observational Phase 2, Group I

Other

Noninterventional study

Observational Phase 2, Group II

Other

Noninterventional study

Observational Phase 3

Other

Noninterventional study

Primary outcomes

  1. 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

  1. Number of Treatment Burdens Identified

    Time frame: Up to 4 months

    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.

  2. Number of Barriers to COPD Care in Oncology Clinics

    Time frame: Up to 4 months

    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.

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

    Time frame: Up to 4 months

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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