Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Recurrent Lung Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Caregiver; Metastatic Thymic Carcinoma; Malignant Pleural Neoplasm; Recurrent Thymic Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Palliative Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (embedded palliative care); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Palliative Therapy; Undergo embedded palliative care; Other Names: Symptom Management; Comfort Care; Palliative Treatment; palliation; Symptoms Management; palliative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Carolyn Presley, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Thymus Neoplasms; Lung Neoplasms; Carcinoma; Recurrence; Thymoma; Pleural Neoplasms
• Other Study ID Numbers: OSU-18116; NCI-2018-01209 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No