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OpenTrials
Completed

NCT Number: NCT04662645

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Therapy

Other

Undergo embedded palliative care

Other names: Comfort Care, palliation, palliative care, Palliative Treatment, Symptom Management, Symptoms Management

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Acceptance from providers to assess utilization of palliative care services

    Time frame: 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.

  2. Demand of palliative care services to be evaluated

    Time frame: Up to 12 months

    Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

  3. Capacity and productivity to be evaluated

    Time frame: 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.

  4. Resource assessment of staff and space

    Time frame: 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.

  5. Symptom burden (patient outcome) supportive care screen

    Time frame: Up to 12 months

    Will be assessed using Supportive care screen.

  6. Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung

    Time frame: Up to 12 months

    Will be assessed using Functional Assessment of Cancer Therapy-Lung

  7. Symptom burden (patient outcome) using HADS

    Time frame: Up to 12 months

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

  8. Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)

    Time frame: Up to 12 months

    Will be assessed using National Comprehensive Cancer Network distress thermometer

  9. Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)

    Time frame: Up to 12 months

    Anxiety assessed using the Hospital Anxiety and Depression Scale

  10. Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)

    Time frame: Up to 12 months

    Depression assessed using the Hospital Anxiety and Depression Scale

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

    Time frame: Up to 12 months

    Functional status assessment using Functional Activities Scale (FAS)

  12. Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)

    Time frame: Up to 12 months

    Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)

  13. Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)

    Time frame: Up to 12 months

    Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)

  14. Work/social needs assessed using SCNS- P and C (Caregiver outcome)

    Time frame: Up to 12 months

    Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)

  15. Information needs assessed using SCNS- P and C (Caregiver outcome)

    Time frame: Up to 12 months

    Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)

  16. Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)

    Time frame: Up to 12 months

    Ohio State Palliative Care Provider survey used to assess perceived barriers to referral

  17. Health care utilization outcomes

    Time frame: Up to 12 months

    Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.

Secondary outcomes

  1. Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model

    Time frame: Up to 12 months

    evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 10, 2020
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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