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. (ALLAN)

September 10, 2025 updated by: Lund University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Contact with palliative care unit versus contact when needed.
Other: Contact with palliative care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life, such as pain, anxiety.
Time Frame: 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.
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
Time Frame
Survival
Time Frame: Approximately 12 months.
Approximately 12 months.

Other Outcome Measures

Outcome Measure
Time Frame
Numbers of chemotherapy cycles
Time Frame: Approximately 12 months.
Approximately 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Mikael Segerlantz, MD, PhD, Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimated)

September 23, 2014

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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