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

Ohio State University Comprehensive Cancer Center68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Caregiver Malignant Pleural Neoplasm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 12 months

Symptom burden (patient outcome) supportive care screen

Will be assessed using Supportive care screen.

Time frame: Up to 12 months

Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung

Will be assessed using Functional Assessment of Cancer Therapy-Lung

Time frame: Up to 12 months

Symptom burden (patient outcome) using HADS

Will be assessed using Hospital Anxiety and Depression Scale (HADS)

Time frame: 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

Time frame: Up to 12 months

Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)

Anxiety assessed using the Hospital Anxiety and Depression Scale

Time frame: Up to 12 months

Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)

Depression assessed using the Hospital Anxiety and Depression Scale

Time frame: Up to 12 months

Functional status assessed using Functional Activities Scale (patient outcome)

Functional status assessment using Functional Activities Scale (FAS)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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.

Time frame: Up to 12 months

Secondary Outcomes

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

Time frame: Up to 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes