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

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.

Inclusion criteria

FOR PATIENTS:

• Able to speak and understand English
• Over age 18
• NEW diagnosis, recurrence, or progression of an advanced stage cancer within THIRTY days of the date the patient was informed of the diagnosis by his/her oncology clinician.
• Estimated survival of 2 years or less
• Diagnosed with an advanced stage cancer such as one of the following:

• Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell
• Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR - and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis
• Gastrointestinal (GI) Cancers: Unresectable stage III or IV
• Genitourinary (GU) Cancers: Stage IV (for prostate cancer inclusion is limited to persons with hormone refractory prostate cancer)
• Brain Cancer: Unresectable, Grade IV
• Melanoma, Stage IV
• Hematologic Malignancies -Leukemia (e.g. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL) - advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, "older age" -Lymphoma- Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma -Multiple Myeloma - elevated β2-microglobulin, albumin <3.5, PCLI >1%, CRP >6µg/mL, elevated LDH, plasmablastic morphology, abnormal. chromosome 13.
• Completion of baseline interview

Inclusion criteria

FOR PATIENTS FOR BIOMARKER SUB-STUDY:

• Only patients with lung, breast, GI, GU cancer are eligible

Inclusion criteria

FOR CAREGIVERS:

• Able to read and understand English
• Anyone identified by the patient as "a person who knows you well & is involved in your medical care".

PATIENT EXCLUSION CRITERIA:

• Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18)
• Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
• Patients will not be excluded if they do not identify a caregiver
• Prior involvement with palliative care service within the last year
• Minimum predicted survival of less than 12 weeks (3 months)

PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:

• Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications
• Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times.

CAREGIVER EXCLUSION CRITERIA:

• Unwilling to participate in study.