Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Role of Early Systematic Best Palliative Care Versus on Request Palliative Care Consultation During Standard Oncologic Treatment for Patients With Advanced Gastric or Pancreatic Cancers: a Randomized, Controlled, Multicenter Trial.
Brief Summary: Title: The role of early systematic best palliative care versus on request palliative care consultation during standard oncologic treatment for patients with advanced gastric or pancreatic cancers: a randomized, controlled, multicenter trial.

Description of Study Treatment:

1. Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients.

   The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs.

   Palliative care doctor must have the possibility to decide about organizational arrangements.

   He has to perform the palliative care visit according to Temel indications.
2. Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.

Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.

Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.


Options:
A: 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
B: Inclusion Criteria:

* Age ≥ 18 years and \<75 years;
* Adequate knowledge about the cancer diagnosis;
* Starting first line palliative antineoplastic treatment;
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤ 2;
* Life expectancy\> 6 months and \<24 months (as per the medical oncologist);
* Must have on the following diagnoses:

Metastatic or unresectable recurrent breast cancer; Stage IIIC or IV recurrent platinum-resistant ovarian cancer; Metastatic or unresectable recurrent cervix cancer; Metastatic or unresectable recurrent endometrial cancer; Metastatic or unresectable recurrent head and neck cancer (after previous radiotherapy); Hormone-refractory metastatic or unresectable recurrent prostate cancer; Metastatic or unresectable recurrent genitourinary cancer; Metastatic or unresectable recurrent non-small cell lung cancer; Extensive-stage or recurrent small cell lung cancer; Metastatic or unresectable recurrent gastrointestinal cancer;

Exclusion Criteria:

* Currently undergoing any psychological treatment due to a psychological disorder;
* Currently using antidepressants to treat depressive disorders and / or anxiety;
* Any cognitive deficit or attention problem that could interfere in the ability to answer questionnaires or understand the study aims (as per investigator);
* Current or previous established diagnosis of any of the following psychological conditions: Substance-Related Disorders; Schizophrenia and Other Psychotic Disorders; Mood Disorders (Depressive Disorders, Bipolar Disorders); Anxiety Disorders; Dissociative Disorders; Personality Disorders; and / or a history of suicide attempt;
* Patients with single resected metastasis;
* Any co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.
* Patients unable to go to the hospital for the study visits, regardless of the reason.
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:

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.

Answer: D