Chronic Obstructive Pulmonary Disease, Head and Neck Cancer, Lung Cancer
Conditions
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.
Interventions
OTHERObservational Phase 1
Noninterventional study
OTHERObservational Phase 2, Group I
Noninterventional study
OTHERObservational Phase 2, Group II
Noninterventional study
OTHERObservational Phase 3
Noninterventional study
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
National Center for Advancing Translational Sciences (NCATS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Designing a Novel COPD Care Pathway | Up to 60 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Burdens Identified | Up to 4 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 up to four months later. 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 Clinics | Up to 4 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 up to four months later 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 Patients | Up to 4 months | 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 up to four months later. 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Lycan, MD
Wake Forest Baptist Comprehensive Cancer Center
Outcome results
None listed