COPD Care Pathway Among Patients With Cancer

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Chronic Obstructive Pulmonary Disease; Lung Cancer; Head and Neck Cancer

Treatments: Other: Observational Phase 3; Other: Observational Phase 2, Group I; Other: Observational Phase 2, Group II; Other: Observational Phase 1

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05984680

P30CA012197 (U.S. NIH Grant/Contract)

IRB00120161

K12TR004931 (U.S. NIH Grant/Contract)

ONC-LUN-2406 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

100 participants in 4 patient groups

Observational Phase 1

Description:

Participants complete surveys

Treatment:

Other: Observational Phase 1

Observational Phase 2, Group I

Description:

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

Treatment:

Other: Observational Phase 2, Group I

Observational Phase 2, Group II

Description:

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

Treatment:

Other: Observational Phase 2, Group II

Observational Phase 3

Description:

A subset of interested participants from Phase 2 participate in a workshop on study to develop a final draft of the COPD care pathway.

Treatment:

Other: Observational Phase 3