Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.

Study Overview
=================
Brief Summary
-----------------
In this trial, patients with cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Participating patients will be randomized between early contact with a palliative care unit, or contact with a palliative care unit when needed. The objectives with the trial is to investigate if an early establishment with a palliative care unit will have a positive impact on the patients quality of life, this also applies for the nearest relative, survival, and if a difference in numbers of chemotherapy cycles can be detected.

Official Title
-----------------
Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.

Conditions
-----------------
Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Contact with palliative care unit.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with tumor in upper gastrointestinal canal, who is going to start treatment with first line palliative chemotherapy Patients with colorectal cancer, who is going to start treatment with second line palliative chemotherapy Signed written informed concent Exclusion Criteria: Patients with neuroendocrine tumor Patients with already ongoing chemotherapy Patients with already established contact with palliative care unit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contact with palliative care unit versus contact when needed.<br> | Other: Contact with palliative care unit.<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life, such as pain, anxiety. | Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year. | At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Approximately 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Neoplasms, Depression, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Palliative chemotherapy, Palliative care, Palliative treatment, Quality of life, Quality of life for relatives, Survival