NCT01245621

Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)

Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Later entry group	1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert Information (COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and 2. Comprehensive Palliative Care Team Assessment \& Management Plan.
BEHAVIORAL	Early palliative care intervention	1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert information(COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and 2. Comprehensive Palliative Care Team Assessment \& Management Plan.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-11-22
• Last updated: 2014-01-03

Locations

7 sites across 1 country: United States