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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01209 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.
PRIMARY OBJECTIVES:
I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
IV. To analyze health care utilization among participants receiving embedded onco-palliative care.
OUTLINE:
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
After completion of study, patients are followed for up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (embedded palliative care) | Experimental | Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Therapy | Other | Undergo embedded palliative care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance from providers to assess utilization of palliative care services | Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. | Up to 12 months |
| Demand of palliative care services to be evaluated | Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. | Up to 12 months |
| Capacity and productivity to be evaluated | Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. | Up to 12 months |
| Resource assessment of staff and space | Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. | Up to 12 months |
| Symptom burden (patient outcome) supportive care screen | Will be assessed using Supportive care screen. | Up to 12 months |
| Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung | Will be assessed using Functional Assessment of Cancer Therapy-Lung | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model | evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Presley, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 20, 2022 | Sep 14, 2023 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Symptom burden (patient outcome) using HADS | Will be assessed using Hospital Anxiety and Depression Scale (HADS) | Up to 12 months |
| Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome) | Will be assessed using National Comprehensive Cancer Network distress thermometer | Up to 12 months |
| Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome) | Anxiety assessed using the Hospital Anxiety and Depression Scale | Up to 12 months |
| Depression assessment using Hospital Anxiety and Depression Scale (patient outcome) | Depression assessed using the Hospital Anxiety and Depression Scale | Up to 12 months |
| Functional status assessed using Functional Activities Scale (patient outcome) | Functional status assessment using Functional Activities Scale (FAS) | Up to 12 months |
| Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome) | Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) | Up to 12 months |
| Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome) | Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) | Up to 12 months |
| Work/social needs assessed using SCNS- P and C (Caregiver outcome) | Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) | Up to 12 months |
| Information needs assessed using SCNS- P and C (Caregiver outcome) | Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) | Up to 12 months |
| Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome) | Ohio State Palliative Care Provider survey used to assess perceived barriers to referral | Up to 12 months |
| Health care utilization outcomes | Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events. | Up to 12 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D000070659 | Patient Comfort |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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