Back to resultsCOPD Care Pathway Among Patients With Cancer
Primary Purpose
Chronic Obstructive Pulmonary Disease, Lung Cancer, Head and Neck Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surveys and Interviews - Arm A
COPD Care Pathway
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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.
Sites / Locations
- Wake Forest Baptist Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Aim A - Participants and Providers
Arm B - Participants only COPD Care Pathway
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05984680
First Posted
August 1, 2023
Last Updated
October 2, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05984680
Brief Title
COPD Care Pathway Among Patients With Cancer
Official Title
Mixed-Methods Implementation of a COPD Care Pathway Among Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Lung Cancer, Head and Neck Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aim A - Participants and Providers
Arm Type
Other
Arm Description
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.
Arm Title
Arm B - Participants only COPD Care Pathway
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Surveys and Interviews - Arm A
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
COPD Care Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants that Agree the COPD Pathway is Feasible - Feasibility Implementation Measure (FIM)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Barriers Identified to the Implementation of a COPD Intervention for Community Oncology Clinics
Description
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.
Time Frame
14 months
Title
Number of Participants to Find the COPD Care Pathway Acceptable - Acceptability Implementation Measure (AIM).
Description
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.
Time Frame
14 months
Title
Number of Participants to Find the COPD Care Pathway Appropriate - Appropriateness Implementation Measure (AIM).
Description
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.
Time Frame
14 months
Title
Number of Clinics Ready to Adopt the COPD Care Pathway - Organizational Readiness for Implementing Change (ORIC)
Description
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.
Time Frame
14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Participant Coordinator
Phone
336-716-6700
Email
btopalog@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lycan, MD
Organizational Affiliation
Wake Forest Baptist Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Participant Coordinator
Phone
336-716-6700
First Name & Middle Initial & Last Name & Degree
Thomas Lycan, Jr, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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COPD Care Pathway Among Patients With Cancer
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