Clinical trial NCT05984680: COPD Care Pathway Among Patients With Cancer
Official title: User-Centered Design of a COPD Care Pathway for Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Lung Cancer
Head and Neck Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of Designing a Novel COPD Care Pathway
timeFrame: 12 months
Secondary outcomes:
measure: Number of Treatment Burdens Identified
timeFrame: 12 months
measure: Number of Barriers to COPD Care in Oncology Clinics
timeFrame: 12 months
measure: Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Thomas Lycan, MD
role: PRINCIPAL_INVESTIGATOR
References: