Please select the eligibility criteria that correspond to the clinical trial below.
Title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
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.


Options:
A: Inclusion Criteria:

1. diagnosis of inoperable locally advanced and/or metastatic gastric or pancreatic cancers within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
2. patients eligible for chemotherapy and/or new target drugs treatments for metastatic or advanced disease;
3. ECOG PS 0-2 (Appendix A);
4. life expectancy \>2 months;
5. both sex;
6. age ≥18 years;
7. all ethnic background;
8. subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
9. written informed consent (Appendix B);
10. palliative care visit must be performed by a dedicated physician/team different from the medical oncology group.

Exclusion Criteria:

1. patients already receiving care from the palliative care service;
2. prior chemotherapy and/or new target drugs treatments for metastatic or advanced disease.
B: 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.
6. Completion of baseline interview

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.
C: Inclusion Criteria:

* COPD defined according to GOLD criteria (FEV1/FVC \< 70%) stage III or IV (FEV1 \< 50% predicted)

  * and/or long term treatment with either domiciliary oxygen or home mechanical ventilation
  * and or one or more hospital admissions in the previous year for an acute exacerbation

Exclusion Criteria:

* Moderate or severe cognitive impairment (MMSE\<20)
D: Inclusion Criteria:

Patients with life-limiting cancer (prognosis of approximately 1 year) are eligible if:

* Patients are within 12 weeks of referral from an other hospital after receiving first line treatment or within 8 to 12 weeks of a new diagnosis (histological and cytological confirmed):

  * Metastatic and advanced pancreatic, stomach, oesophageal and biliary tract adenocarcinoma;
  * Metastatic or advanced NSCLC (stage IIIB or IV) or metastatic SCLC,
  * Malignant pleural mesothelioma
  * Metastatic or advanced head and neck cancer (stage III or IV)
* Patients are within 12 weeks of progression after receiving treatment and have an prognosis of approximately 1 year:

  * Metastatic and locally advanced colorectal cancer, with progression after second line treatment
  * Metastatic or advanced prostate carcinoma, after second line treatment
  * Advanced breast cancer with visceral and/or brain metastasis, with progression on second or third line treatment
  * Metastatic melanoma,
  * Metastatic or advanced kidney cancer,
  * Metastatic or advanced bladder cancer after first line treatment,

An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and ability to read and respond to questions in Dutch.

Exclusion criteria:

* Patients under 18 years old
* Patients with impaired cognition
* Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.

Answer: B