Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Head and Neck Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Immunomodulating Agents

Arm A will use the user-centered design process to survey pulmonology content experts, oncology providers, and patients and interview a smaller subset. Specifically, we will measure the perceived efficacy of various components of COPD management using a survey of patients with thoracic cancer and oncology providers.

Investigators will use the COPD care pathway developed by Arm A as the intervention in single-arm pilot study to test its feasibility and other implementation outcomes.

For Arm A, this outpatient study will administer surveys, interviews, concept mapping exercises, guided tours of oncology clinics, design team workshops, and phone calls for follow-up questions

Surveys and Interviews - Arm A

The COPD care pathway will consist of an initial assessment followed by monthly follow-up assessments, which occur during regularly scheduled immunotherapy infusions. At each of these three visits, the study team will administer symptom measures, counsel participants on the management of COPD, and give algorithm-generated general recommendations to the patient and provider regarding possible options for COPD-directed care.

COPD Care Pathway

Thomas Lycan, MD

The research objective for this pilot study is to design the first care pathway to implement COPD care in a community oncology clinic. Using a mixed-methods user-centered design process, investigators will ensure the feasibility of evidence-based practices in this setting.

The results of this pilot study will directly inform a randomized controlled trial to measure whether COPD control reduces hospitalization risk.

Primary Objective: To measure feasibility of a novel chronic obstructive pulmonary disease (COPD) care pathway in an oncology clinic.

Secondary Objective(s)

* To assess barriers to implementing of a COPD intervention for community oncology clinics using surveys and interviews of patients and providers.
* To measure acceptability of a novel COPD care pathway in an oncology clinic.
* To measure appropriateness of a novel COPD care pathway in an oncology clinic.
* To measure organizational readiness of a novel COPD care pathway in an oncology clinic.

There are two aims to this trial. Arm A is for participants and providers with study intervention consisting of surveys/interviews and an assessment to design a COPD care pathway for implementation in community oncology clinics, evaluated in Arm B.

Aim B is for participants only to evaluate feasibility of COPD care pathway in oncology clinics.

COPD Care Pathway Among Patients With Cancer

Mixed-Methods Implementation of a COPD Care Pathway Among Patients With Cancer

Using a four-item questionnaire designed to measure perceived feasibility of COPD care pathway using a Likert scale from 1-5 (1 = "completely disagree," 5 = "completely agree") with a mean item score of ≥3 ("neither agree nor disagree"), (score range range minimum score of 4 to maximum score of 20 ) among answered items defined as higher scores indicating a positive outcome.

Using surveys and qualitative interviews conducted with a purposive sample of oncology patients and providers to identify the barriers to implementation present in some clinics but not others.

Using a four-item questionnaire designed to measure the perceived acceptability of the COPD care pathway using a Likert scale from 1-5 (1 = "completely disagree," 5 = "completely agree") with a mean item score of ≥3 ("neither agree nor disagree") among answered items defined as a positive outcome. Minimum score of 4, maximum score of 20. Higher scores indicated a more positive outcome.

Organizational readiness for implementing change to optimize COPD care among oncology providers in an oncology clinic with the validated 12-item Organizational Readiness for Implementing Change (ORIC). Each of the 12 ORIC items use a Likert scale from 1-5 (1 = "disagree," 5 = "agree") with a mean item score of ≥3 ("neither agree nor disagree") among answered items defined as a positive outcome. Minimum score of 12, maximum score of 60. Higher scores indicated a more positive outcome. Investigators will use a baseline adjusted model to assess pre-post change scores in organizational readiness (ORIC) to adopt the COPD 2 pathway.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
COPD Care Pathway Among Patients With Cancer	NCT05984680	Chronic Obstruc... Lung Cancer Head and Neck C...	Surveys and Int... COPD Care Pathw...	18 Years -	Wake Forest University Health Sciences
COPD Care Pathway Among Patients With Cancer	NCT05984680	Chronic Obstruc... Lung Cancer Head and Neck C...	Surveys and Int... COPD Care Pathw...	18 Years -	Wake Forest University Health Sciences
COPD Care Pathway Among Patients With Cancer	NCT05984680	Chronic Obstruc... Lung Cancer Head and Neck C...	Surveys and Int... COPD Care Pathw...	18 Years -	Wake Forest University Health Sciences

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