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A Randomized Study of Early Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311465
Recruitment Status : Withdrawn (Feasibility issues)
First Posted : December 8, 2014
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Palliative Care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Study Start Date : December 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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 Name: 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.



Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. PROMIS Depression Scale [ Time Frame: 1 year ]
    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.

  2. PROMIS Anxiety Scale [ Time Frame: 1 year ]
    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.

  3. Hospitalizations [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311465


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Gordon Bernard, MD Vanderbilt University Medical Center
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Responsible Party: Gordon Bernard, Professor of Medicine; Associate Vice-Chancellor for Research, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02311465    
Other Study ID Numbers: 141854
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Gordon Bernard, Vanderbilt University:
Palliative Care