Clinical trial NCT02246725: 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.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer
Keywords: 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
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2014-09-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tumor in esophagus, stomach, pancreas liver-biliary passage receiving first line palliative chemotherapy, or patients with colorectal cancer receiving second line palliative chemotherapy.

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.


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

Primary outcomes:
measure: Quality of Life, such as pain, anxiety.
timeFrame: 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 outcomes:
measure: Survival
timeFrame: Approximately 12 months.
Other outcomes:
measure: Numbers of chemotherapy cycles
timeFrame: Approximately 12 months.
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden
name: Mikael Segerlantz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: