Advanced Cancer Clinical Trial
Official title:
Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care
intervention designed to improve quality of life, mood, and symptom management for patients
with an advanced stage cancer and their caregivers.
The primary aims of this clinical trial are to determine whether a palliative care
intervention (introduced immediately or 12 weeks after diagnosis) can improve survival,
quality of life, mood, symptom intensity and end-of-life care.
In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. Palliative
care strives to improve quality of life (QOL) and to prevent "bad deaths" by providing
expert, interdisciplinary care to manage the effects of disease and treatment. Effective
end-of-life (EOL) care depends upon proactive, patient-centered interventions to prepare
patients and families for the challenges of terminal illness. We were able to demonstrate
the feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention in
improving quality of life and mood in our previous studies ENABLE I and ENABLE II; however,
a number of gaps in our knowledge remain.
Patients will be randomized to begin the intervention either immediately or 12 weeks after a
new diagnosis of advanced or recurrent cancer. This phone-based intervention consists of: 1)
an Advanced Practice Palliative Care Nurse Interventionist instituting 1a) a 6-session
manualized patient curriculum- Charting Your Course (CYC), 1b) a 3-session manualized,
caregiver curriculum- the Creativity Optimism Planning Expert information (COPE) program,
and 1c) on-going patient and caregiver follow up; and 2) Palliative Care Team Comprehensive
Assessment & Management.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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