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

NCT04662645 | Completed DMC

• 2 other identifiers: OSU-18116NCI-2018-01209
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (17)

• 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.

  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.

  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.

  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.

  Up to 12 months

• Symptom burden (patient outcome) supportive care screen

  Will be assessed using Supportive care screen.

  Up to 12 months

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

  Will be assessed using Functional Assessment of Cancer Therapy-Lung

  Up to 12 months

• Symptom burden (patient outcome) using HADS

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

  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

  Up to 12 months

• Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)

  Anxiety assessed using the Hospital Anxiety and Depression Scale

  Up to 12 months

• Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)

  Depression assessed using the Hospital Anxiety and Depression Scale

  Up to 12 months

• Functional status assessed using Functional Activities Scale (patient outcome)

  Functional status assessment using Functional Activities Scale (FAS)

  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)

  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)

  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)

  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)

  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

  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.

  Up to 12 months

Secondary Outcomes (1)

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

  Up to 12 months

Study Arms (1)

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.

Other: Palliative Therapy; Other: Questionnaire Administration

Interventions

Palliative Therapy OTHER

Undergo embedded palliative care

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

Supportive care (embedded palliative care)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (embedded palliative care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Thymoma; Lung Neoplasms

Interventions

Palliative Care; Patient Comfort

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Carolyn Presley, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: December 10, 2020
• Study Start: December 12, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2020
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)