A Randomized Study of Early Palliative Care
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|ClinicalTrials.gov Identifier: NCT02311465|
Recruitment Status : Withdrawn (Feasibility issues)
First Posted : December 8, 2014
Last Update Posted : December 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Other: Palliative Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
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:
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Gordon Bernard, MD||Vanderbilt University Medical Center|