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:

1. Able to speak and understand English

2. Over age 18

3. 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.

4. Estimated survival of 2 years or less

5. 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.

INCLUSION CRITERIA FOR PATIENTS FOR BIOMARKER SUB-STUDY:

1. Only patients with lung, breast, GI, GU cancer are eligible

INCLUSION CRITERIA FOR CAREGIVERS:

1. Able to read and understand English

2. Anyone identified by the patient as "a person who knows you well & is involved in
your medical care".

PATIENT EXCLUSION CRITERIA:

1. 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)

2. Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia,
bipolar disorder, or active substance use disorder)

3. Patients will not be excluded if they do not identify a caregiver

4. Prior involvement with palliative care service within the last year

5. Minimum predicted survival of less than 12 weeks (3 months)

PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:

1. Receiving chronic steroid hormones or unable to schedule specimen collection distant
from chemotherapy from steroid pre-medications

2. Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times.

CAREGIVER EXCLUSION CRITERIA:

1. Unwilling to participate in study.