Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
Brief Summary: The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.

The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).

The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.


Options:
A: 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.
B: Inclusion Criteria:

* Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
* At least 18 years
* Live in the area of the participating hospitals
* No contact with specialised palliative care within the previous year
* At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
* Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
* Written informed consent

Exclusion Criteria:

* Do not understand Danish well enough to participate in the study
* Are judged incapable of co-operating with the trial protocol
C: 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.
D: 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)

Answer: A