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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04662645
Other study ID # OSU-18116
Secondary ID NCI-2018-01209
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2018
Est. completion date December 5, 2020

Study information

Verified date October 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 5, 2020
Est. primary completion date December 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease - Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University - New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies - Patient and caregiver must be able to read and understand consent form - Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation Exclusion Criteria: - Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted - Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment - Patients who are unable to read or understand consent form - Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted

Study Design


Intervention

Other:
Palliative Therapy
Undergo embedded palliative care
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Symptom burden (patient outcome) supportive care screen Will be assessed using Supportive care screen. Up to 12 months
Primary Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung Will be assessed using Functional Assessment of Cancer Therapy-Lung Up to 12 months
Primary Symptom burden (patient outcome) using HADS Will be assessed using Hospital Anxiety and Depression Scale (HADS) Up to 12 months
Primary 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
Primary Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome) Anxiety assessed using the Hospital Anxiety and Depression Scale Up to 12 months
Primary Depression assessment using Hospital Anxiety and Depression Scale (patient outcome) Depression assessed using the Hospital Anxiety and Depression Scale Up to 12 months
Primary Functional status assessed using Functional Activities Scale (patient outcome) Functional status assessment using Functional Activities Scale (FAS) Up to 12 months
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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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