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Brief Title: Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)
Official Title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
Study ID: NCT01245621
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dartmouth-Hitchcock Medical Center - Lebanon, Lebanon, New Hampshire, United States
Dartmouth-Hitchcock Clinic - Manchester, Manchester, New Hampshire, United States
St. Joseph Hospital, Nashua, New Hampshire, United States
Dartmouth-Hitchcock NCCC Nashua, Nashua, New Hampshire, United States
Providence VA Medical Center, Providence, Rhode Island, United States
Mountainview Medical, Berlin, Vermont, United States
Veteran's Administration Hospital, White River Junction, Vermont, United States
Name: Marie A. Bakitas, DNSc, APRN
Affiliation: Dartmouth-Hitchcock Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jennifer P. Frost, RN, MS
Affiliation: Dartmouth-Hitchcock Medical Center
Role: STUDY_DIRECTOR