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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Caregiver
• Lung Neoplasms
• Malignant Pleural Neoplasm
• Metastatic Thymic Carcinoma
• Pleural Neoplasms
• Recurrence
• 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
• Thymoma

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

External Links

•   The Jamesline