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

Not Applicable

Completed

• Conditions: Stage IVB Lung Cancer AJCC v8; Caregiver; Malignant Pleural Neoplasm; Metastatic Thymic Carcinoma; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Recurrent Lung Carcinoma; Recurrent Thymic Carcinoma; Stage III Lung Cancer AJCC v8
• Interventions: Other: Palliative Therapy; Other: Questionnaire Administration

• Registration Number: NCT04662645
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2018-06-26
• Study Start: 2018-12-12
• Primary Completion: 2019-12-05
• Study Completion: 2020-12-05
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (embedded palliative care)	Questionnaire Administration	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.
Supportive care (embedded palliative care)	Palliative Therapy	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.

Primary Outcome Measures

Name	Time	Method
Capacity and productivity to be evaluated	Up to 12 months	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.
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)	Up to 12 months	Anxiety assessed using the Hospital Anxiety and Depression Scale
Work/social needs assessed using SCNS- P and C (Caregiver outcome)	Up to 12 months	Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Information needs assessed using SCNS- P and C (Caregiver outcome)	Up to 12 months	Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Demand of palliative care services to be evaluated	Up to 12 months	Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Symptom burden (patient outcome) supportive care screen	Up to 12 months	Will be assessed using Supportive care screen.
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung	Up to 12 months	Will be assessed using Functional Assessment of Cancer Therapy-Lung
Symptom burden (patient outcome) using HADS	Up to 12 months	Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Functional status assessed using Functional Activities Scale (patient outcome)	Up to 12 months	Functional status assessment using Functional Activities Scale (FAS)
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)	Up to 12 months	Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Acceptance from providers to assess utilization of palliative care services	Up to 12 months	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.
Resource assessment of staff and space	Up to 12 months	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.
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)	Up to 12 months	Will be assessed using National Comprehensive Cancer Network distress thermometer
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)	Up to 12 months	Depression assessed using the Hospital Anxiety and Depression Scale
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)	Up to 12 months	Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Health care utilization outcomes	Up to 12 months	Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)	Up to 12 months	Ohio State Palliative Care Provider survey used to assess perceived barriers to referral

Secondary Outcome Measures

Name	Time	Method
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model	Up to 12 months	evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States