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COPD Care Pathway Among Patients With Cancer

Not Applicable
Recruiting
Conditions
Chronic Obstructive Pulmonary Disease
Lung Cancer
Head and Neck Cancer
Interventions
Other: Surveys and Interviews - Arm A
Other: COPD Care Pathway
Registration Number
NCT05984680
Lead Sponsor
Wake Forest University Health Sciences
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Aim A - Participants and ProvidersSurveys and Interviews - Arm AArm 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 B - Participants only COPD Care PathwayCOPD Care PathwayInvestigators 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.
Primary Outcome Measures
NameTimeMethod
Feasibility of Designing a Novel COPD Care Pathway12 months

The feasibility of designing a novel COPD care pathway for patients with cancer that is responsive to mixed methods data by specifically addressing (i) the reduction of treatment burden of patients, (ii) the implementation of important and feasible components of COPD care, and (iii) the adaptation necessary to overcome common barriers to COPD care in the community oncology clinic, with feasibility defined by the agreement of a supermajority of stakeholders at a design team workshop.

Secondary Outcome Measures
NameTimeMethod
Number of Treatment Burdens Identified12 months

Treatment burdens of COPD and cancer as comorbidities will be measured by self-report from patients and providers using surveys, interviews, and guided tours from at least one timepoint, with follow-up data collected from some participants.

The options for the multiple-choice survey questions are based on historical data reporting the following specific features of COPD among patients without cancer: (i) inconsistent knowledge of the diagnosis of COPD,22 (ii) negative connotations of the diagnosis of COPD upon identity, (iii) lack of confidence in the capability of treating COPD, (iv) variable confidence in the skill of self-administering an inhaler, (v) inconsistent behavioral regulation for self-management of COPD, (vi) a goal to consolidate care to fewer appointments, (vii) lack of optimism for the ability to effectively treat COPD for positive consequences, and (viii) intention to utilize expanded access to COPD care.

Number of Barriers to COPD Care in Oncology Clinics12 months

Barriers to COPD care in the oncology clinic will be measured by self-report from patients and providers using surveys, interviews, and guided tours from at least one timepoint, with follow-up data collected from some participants

A quantitative analysis of barriers to COPD care using the data from multiple-choice survey answers of patients and providers to identify which types of barriers are most commonly experienced. The options for the multiple-choice survey questions are based on historical data reporting the following barriers to COPD care among patients without cancer: (i) inadequate information for providers or (ii) patients, (iii) lack of time, (iv) patients having a lack of faith in providers, (v) medical advice that conflicts with patients' perceptions, (vi) a desire for personal responsibility, and (vii) prohibitive cost of COPD care.

Identifying Important and Feasible Components of COPD Care - Best Practices for Cancer Patients12 months

Important and feasible components of COPD care for implementation by a novel care pathway at community oncology clinics will be measured by qualitative and quantitative data collected from oncology patients and providers from at least one timepoint, with follow-up data collected from some participants. Participants will integrate this data using a concept mapping exercise to sort and rank items to identify COPD best practices among patients with cancer.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

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Winston-Salem, North Carolina, United States

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