A Randomized Study of Early Palliative Care

Vanderbilt University

Status: Withdrawn

Conditions: Quality of Life

Treatments: Other: Palliative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02311465

141854

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Palliative Care + Standard of Care

Experimental group

Description:

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.

Treatment:

Other: Palliative Care

Standard of Care

No Intervention group

Description:

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.