Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers
Primary Purpose
Caregiver, Malignant Pleural Neoplasm, Metastatic Thymic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Therapy
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver
Eligibility Criteria
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (embedded palliative care)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Demand of palliative care services to be evaluated
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
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.
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.
Symptom burden (patient outcome) supportive care screen
Will be assessed using Supportive care screen.
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
Will be assessed using Functional Assessment of Cancer Therapy-Lung
Symptom burden (patient outcome) using HADS
Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
Will be assessed using National Comprehensive Cancer Network distress thermometer
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
Anxiety assessed using the Hospital Anxiety and Depression Scale
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
Depression assessed using the Hospital Anxiety and Depression Scale
Functional status assessed using Functional Activities Scale (patient outcome)
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)
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Information needs assessed using SCNS- P and C (Caregiver outcome)
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)
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral
Health care utilization outcomes
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
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care
Full Information
NCT ID
NCT04662645
First Posted
June 26, 2018
Last Updated
August 11, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04662645
Brief Title
Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers
Official Title
Embedded Palliative Care in the Management of Advanced Thoracic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (embedded palliative care)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Palliative Therapy
Other Intervention Name(s)
Comfort Care, palliation, palliative care, Palliative Treatment, Symptom Management, Symptoms Management
Intervention Description
Undergo embedded palliative care
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acceptance from providers to assess utilization of palliative care services
Description
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
Title
Demand of palliative care services to be evaluated
Description
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Time Frame
Up to 12 months
Title
Capacity and productivity to be evaluated
Description
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
Title
Resource assessment of staff and space
Description
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
Title
Symptom burden (patient outcome) supportive care screen
Description
Will be assessed using Supportive care screen.
Time Frame
Up to 12 months
Title
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
Description
Will be assessed using Functional Assessment of Cancer Therapy-Lung
Time Frame
Up to 12 months
Title
Symptom burden (patient outcome) using HADS
Description
Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Time Frame
Up to 12 months
Title
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
Description
Will be assessed using National Comprehensive Cancer Network distress thermometer
Time Frame
Up to 12 months
Title
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
Description
Anxiety assessed using the Hospital Anxiety and Depression Scale
Time Frame
Up to 12 months
Title
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
Description
Depression assessed using the Hospital Anxiety and Depression Scale
Time Frame
Up to 12 months
Title
Functional status assessed using Functional Activities Scale (patient outcome)
Description
Functional status assessment using Functional Activities Scale (FAS)
Time Frame
Up to 12 months
Title
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
Description
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Time Frame
Up to 12 months
Title
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
Description
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Time Frame
Up to 12 months
Title
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
Description
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Time Frame
Up to 12 months
Title
Information needs assessed using SCNS- P and C (Caregiver outcome)
Description
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Time Frame
Up to 12 months
Title
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
Description
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral
Time Frame
Up to 12 months
Title
Health care utilization outcomes
Description
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 Outcome Measure Information:
Title
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
Description
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Presley, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers
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