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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT04662645

Collaborator

(none)

Enrollment

Location

Arm

23.8

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Malignant Pleural Neoplasm Metastatic Thymic Carcinoma Recurrent Lung Carcinoma Recurrent Thymic Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8	Other: Palliative Therapy Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

Actual Study Start Date :

Dec 12, 2018

Actual Primary Completion Date :

Dec 5, 2019

Actual Study Completion Date :

Dec 5, 2020

Arms and Interventions

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: Palliative Therapy Undergo embedded palliative care Other Names: Comfort Care palliation palliative care Palliative Treatment Symptom Management Symptoms Management Other: Questionnaire Administration Ancillary studies

Arm

Intervention/Treatment

Experimental: Supportive care (embedded palliative care)

Other: Palliative Therapy

Undergo embedded palliative care

Other Names:

Comfort Care

palliation

palliative care

Palliative Treatment

Symptom Management

Symptoms Management

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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 (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)
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
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome) [Up to 12 months]
Anxiety assessed using the Hospital Anxiety and Depression Scale
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome) [Up to 12 months]
Depression assessed using the Hospital Anxiety and Depression Scale
Functional status assessed using Functional Activities Scale (patient outcome) [Up to 12 months]
Functional status assessment using Functional Activities Scale (FAS)
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)
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)
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)
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
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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