NCT02311465

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

December 4, 2014

Last Update Submit

December 9, 2015

Conditions

Quality of Life

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • PROMIS Depression Scale

    1 year

  • PROMIS Anxiety Scale

    1 year

  • Hospitalizations

    1 year

Study Arms (2)

Palliative Care + Standard of Care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Palliative CareOTHER

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

Also known as: Support Care
Palliative Care + Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gordon Bernard, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Associate Vice-Chancellor for Research

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

US(1)