Quality of Life
Conditions
Keywords
Palliative Care
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.
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
Interventions
OTHERPalliative 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
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Depression Scale | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed