A Randomized Study of Early Palliative Care

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02311465
• Other study ID #: 141854
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 9, 2015
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No