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CompletedNCT04662645Updated Oct 6, 2026

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

An interventional study of Palliative Therapy and Questionnaire Administration in Caregiver, Malignant Pleural Neoplasm and Metastatic Thymic Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 the 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.

02

Conditions studied

  • 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
03

In context

Thymoma

126 studies on the registry are indexed under Thymoma; 36 are open to participants now.

This study's enrollment of 68 is above the median of 40 across 101 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • 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 · Other: Questionnaire Administration

Interventions

  • OtherPalliative Therapy

    Undergo embedded palliative care

    Also known as: Comfort Care, palliation, palliative care, Palliative Treatment, Symptom Management, Symptoms Management

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Symptom burden (patient outcome) supportive care screen

    Will be assessed using Supportive care screen.

    Time frame: Up to 12 months

  6. 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

  7. Symptom burden (patient outcome) using HADS

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

    Time frame: Up to 12 months

  8. 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

  9. 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

  10. 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

  11. Functional status assessed using Functional Activities Scale (patient outcome)

    Functional status assessment using Functional Activities Scale (FAS)

    Time frame: Up to 12 months

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  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

    Time frame: Up to 12 months

07

Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
08

References and documents

Related links

Study documents

  • Informed consent form · Nov 2, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: index terms and documents
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 2 other changes: index terms and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04662645
Lead sponsor
Ohio State University Comprehensive Cancer Center
Responsible party
Carolyn Presley (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Dec 10, 2020
Start date
Dec 12, 2018
Primary completion
Dec 5, 2019
Completion
Dec 5, 2020
Last update
Oct 6, 2026

Study contacts

Carolyn Presley, MD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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