CaregiverNCT04662645
Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers
A study testing Palliative Therapy and Questionnaire Administration in people with Caregiver and Malignant Pleural Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Malignant Pleural Neoplasm, Metastatic Thymic Carcinoma
- What is being tested?
- Palliative Therapy and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 5 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Embedded Palliative Care in the Management of Advanced Thoracic Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Caregiver, Malignant Pleural Neoplasm, Metastatic Thymic Carcinoma, Recurrent Lung Carcinoma, Recurrent Thymic Carcinoma, Stage III Lung Cancer AJCC v8
- Being tested
- Palliative Therapy, Questionnaire Administration
- Medical subject headings
- Thymoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative TherapyOther
Also called Comfort Care, palliation, palliative care, Palliative Treatment
Undergo embedded palliative care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (embedded palliative care) | Experimental | 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. Receives: Other: Palliative Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Symptom burden (patient outcome) supportive care screen
Will be assessed using Supportive care screen.
Measured: Up to 12 months
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
Will be assessed using Functional Assessment of Cancer Therapy-Lung
Measured: Up to 12 months
Symptom burden (patient outcome) using HADS
Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Measured: 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
Measured: Up to 12 months
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
Anxiety assessed using the Hospital Anxiety and Depression Scale
Measured: Up to 12 months
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
Depression assessed using the Hospital Anxiety and Depression Scale
Measured: Up to 12 months
Functional status assessed using Functional Activities Scale (patient outcome)
Functional status assessment using Functional Activities Scale (FAS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (1)
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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start12 Dec 2018
- Primary completion5 Dec 2019
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Presley, Ohio State University Comprehensive Cancer Center
- Investigators
- Carolyn Presley, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662645
- Sponsor's protocol ID
- OSU-18116
- Other IDs
- NCI-2018-01209
- Status last verified
- Oct 2023
- First submitted
- 26 Jun 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No