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 feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention;however, a number of gaps in our knowledge remain. The proposed study is a logical extension of that work. This randomized controlled clinical trial will determine whether a COPC intervention (introduced immediately or 12 weeks after diagnosis) can improve clinical outcomes and end-of-life (EOL) care for patients with advanced cancer and their caregivers. We will also examine potential mechanisms, mediators, and moderators whereby the intervention has its effects. Exploratory aims will investigate the feasibility of recruiting patients with less common solid tumors and hematological malignancies, the patterns of stress and immune biomarkers, and the biomarkers'relationship to QOL, mood, symptoms, and survival. 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, 1b) a 4-session manualized, caregiver curriculum- the COPE program, and 1c) on-going patient and caregiver follow up;and 2) Palliative Care Team Comprehensive Assessment &Management. Patients will complete baseline questionnaires about QOL, depression, and symptoms. Caregivers will complete questionnaires on caregiver burden, and grief. Questionnaires will be completed using a web-based portal at 6, 12, and 18 weeks, and every 12 weeks thereafter until the patients'death or study completion. Three months after a participant's death, caregivers will be asked to complete an after death questionnaire about the quality of care the patient received while dying. Saliva and blood samples will be collected at baseline and 12 and 24 weeks from patients who choose to participate in the study to examine biomarkers of stress and immune function. Quantitative and qualitative analyses will be performed to determine EOL outcomes of early vs. later entry into palliative care.

Public Health Relevance

In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. This study will determine whether a concurrent model of palliative cancer care (introduced at diagnosis or 12 weeks after diagnosis) can improve end-of-life (EOL) care for patients with advanced cancer. We will ask patients to complete surveys on quality of life, depression, and symptoms and we will ask their caregivers to complete surveys on burden and the quality of care the patient received while dying. In addition, we will ask some patients to provide blood and saliva samples to determine if this care affects their biological immunity and stress responses. Findings from this study could help to determine guidelines and improve EOL care for underserved, vulnerable cancer patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR011871-03
Application #
8121633
Study Section
Special Emphasis Panel (ZNR1-REV-W (04))
Program Officer
Aziz, Noreen M
Project Start
2009-09-30
Project End
2013-07-31
Budget Start
2011-08-01
Budget End
2013-07-31
Support Year
3
Fiscal Year
2011
Total Cost
$446,900
Indirect Cost
Name
Dartmouth College
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755
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Dionne-Odom, J Nicholas; Azuero, Andres; Lyons, Kathleen D et al. (2015) Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol 33:1446-52
Bakitas, Marie A; Elk, Ronit; Astin, Meka et al. (2015) Systematic Review of Palliative Care in the Rural Setting. Cancer Control 22:450-64
Dionne-Odom, J Nicholas; Kono, Alan; Frost, Jennifer et al. (2014) Translating and testing the ENABLE: CHF-PC concurrent palliative care model for older adults with heart failure and their family caregivers. J Palliat Med 17:995-1004
Maloney, Cristine; Lyons, Kathleen Doyle; Li, Zhongze et al. (2013) Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens. Palliat Med 27:375-83

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