Clinical trial NCT04662645: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Acceptance from providers to assess utilization of palliative care services
timeFrame: Up to 12 months
measure: Demand of palliative care services to be evaluated
timeFrame: Up to 12 months
measure: Capacity and productivity to be evaluated
timeFrame: Up to 12 months
measure: Resource assessment of staff and space
timeFrame: Up to 12 months
measure: Symptom burden (patient outcome) supportive care screen
timeFrame: Up to 12 months
measure: Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
timeFrame: Up to 12 months
measure: Symptom burden (patient outcome) using HADS
timeFrame: Up to 12 months
measure: Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
timeFrame: Up to 12 months
measure: Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
timeFrame: Up to 12 months
measure: Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
timeFrame: Up to 12 months
measure: Functional status assessed using Functional Activities Scale (patient outcome)
timeFrame: Up to 12 months
measure: Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
timeFrame: Up to 12 months
measure: Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
timeFrame: Up to 12 months
measure: Work/social needs assessed using SCNS- P and C (Caregiver outcome)
timeFrame: Up to 12 months
measure: Information needs assessed using SCNS- P and C (Caregiver outcome)
timeFrame: Up to 12 months
measure: Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
timeFrame: Up to 12 months
measure: Health care utilization outcomes
timeFrame: Up to 12 months
Secondary outcomes:
measure: Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Carolyn Presley, MD
role: PRINCIPAL_INVESTIGATOR
References: