A Randomized Study of Early Palliative Care

A Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Oncology Care Alone in Patients With Non-colorectal Gastrointestinal Malignancies.

The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life
• Intervention / Treatment: Other: Palliative Care

Detailed Description

The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.

Secondary personalized palliative care outcomes are expected to include:

• Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
• Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• -Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
• Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
• Ability to read and respond to questions in English
• Permission of oncology physician

Exclusion Criteria:

• -Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
• Participation in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palliative Care + Standard of Care; Consenting patients will be approached by a research nurse to complete quality of life questionnaires (baseline measures) either in the oncology clinics or infusion clinics. Patients assigned to early palliative care will meet with a member of the palliative care team after enrollment and completion of the initial questionnaires to receive and review patient-oriented materials detailing palliative care services. Patients will then receive a comprehensive initial consult with a palliative care provider (a trained physician, nurse or nurse practitioner). Additional consults with the palliative care service will be scheduled approximately every 6 weeks for the duration of the study period (one year) at the discretion of the patient and palliative care provider.	Other: Palliative Care; Components of the palliative care service intervention are expected to include: Establishment of a palliative care plan; Care coordination by palliative care team; Informational, patient friendly materials supporting Palliative Care; Communication by palliative care team to all providers and teams involved in patient's care; Systematic collection of information, including identification of surrogate or health care proxy and advance care planning; Questionnaires capturing health related quality of life at regular intervals throughout the intervention period; Other Names: Support Care
No Intervention: Standard of Care; Patients will receive standard care from their oncologist. An assessment of health related quality of life will be conducted at regular oncology clinic visits at baseline and 3,6,9,and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire	The FACT Measurement System is a group of questions which measure health-related quality of life (QOL) in cancer patients. The FACT-G is a 26-item version that addresses multiple QOL dimensions including physical well-being, functional well-being, emotional well-being and social well-being. The response format of the FACT Measurement System consists of a 5-point Likert scale.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Depression Scale	Patient-Reported Outcome Measurement Information System (PROMIS) Depression scale is a highly reliable, validated, precise measures of patient-reported health status for physical, mental, and social well-being. The domains of depression are measured through four targeted questions each on a 5 point Likert scale.	1 year
PROMIS Anxiety Scale	Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety scale is a highly reliable, validated, precise measures of patient-reported health status for physical, mental, and social well-being. The domains of anxiety are measured through four targeted questions each on a 5 point Likert scale.	1 year
Hospitalizations	Patient level data will be obtained for this study through retrospective chart review. Data to be collected from patients' charts include oncology medications and treatments, outcomes and interventions over the course of treatment (surgeries, adverse events, death), and hospitalizations. Clinical interventions, treatments, and events extracted from the charts will inform the investigators analyses regarding health care resource utilization.	1 year

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Gordon Bernard, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Palliative Care
• Other Study ID Numbers: 141854