COPD Care Pathway Among Patients With Cancer

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Cancer; Chronic Obstructive Pulmonary Disease; Lung Cancer
• Intervention / Treatment: Other: Surveys and Interviews - Arm A; Other: COPD Care Pathway

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgul Topaloglu; Phone Number: 336-716-0248; Email: btopalog@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center
      • Principal Investigator: Thomas Lycan, Jr, MD
      • Contact: Birgul Topaloglu; Phone Number: 336-716-0248; Email: btopalog@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Arm A only):

• The participant meets one of the following criteria: (a) a patient known or suspected to have COPD and currently or have ever previously received immunotherapy for any type of cancer (b) a provider who currently works at least part time in a medical oncology clinic, or (c) a provider who currently works at least part time providing care for patients with known or suspected COPD. In the context of this study, a provider is defined as a physician, advanced practice provider, nurse, or respiratory therapist.
• Ability to understand and be willing to sign an IRB-approved informed consent document directly.

Exclusion Criteria (Arm A only)

- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence to study requirements.

Inclusion Criteria (Arm B only)

• Radiographic evidence or suspected symptoms of COPD (e.g. wheezing, coughing, chest tightness, dyspnea).
• A documented diagnosis of cancer from a primary site either in the lung (any type or subtype) or head/neck (mucosal squamous subtype only).
• Treatment with one or more immune checkpoint inhibitor that is either (a) planned to start within the next six weeks, or (b) has already been started within the last six weeks.
• Eighteen years old or greater. Given the rare co-occurrence of respiratory tract cancer and COPD in the pediatric patient population, their inclusion would make interpretation of data difficult.
• ECOG performance status of 0-2.
• Life expectancy of greater than three months.
• Ability to understand and be willing to sign an IRB-approved informed consent document directly.

Exclusion Criteria (Arm B only)

• Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
• History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).
• Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aim A - Participants and Providers; 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.	Other: Surveys and Interviews - Arm A; 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
Other: Arm B - Participants only COPD Care Pathway; 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.	Other: COPD Care Pathway; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants that Agree the COPD Pathway is Feasible - Feasibility Implementation Measure (FIM)	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Barriers Identified to the Implementation of a COPD Intervention for Community Oncology Clinics	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.	14 months
Number of Participants to Find the COPD Care Pathway Acceptable - Acceptability Implementation Measure (AIM).	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.	14 months
Number of Participants to Find the COPD Care Pathway Appropriate - Appropriateness Implementation Measure (AIM).	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.	14 months
Number of Clinics Ready to Adopt the COPD Care Pathway - Organizational Readiness for Implementing Change (ORIC)	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.	14 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Thomas Lycan, MD, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WFBCCC 99723; P30CA012197 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No