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.

NCT02246725 | Completed

• 1 other identifier: MS01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survival

  Approximately 12 months.

Other Outcomes (1)

• Numbers of chemotherapy cycles

  Approximately 12 months.

Study Arms (1)

Contact with palliative care unit versus contact when needed.

Other: Contact with palliative care unit.

Interventions

Contact with palliative care unit. OTHER

Contact with palliative care unit versus contact when needed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with neuroendocrine tumor
• Patients with already ongoing chemotherapy
• Patients with already established contact with palliative care unit

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

• Bojesson A, Brun E, Eberhard J, Segerlantz M. Quality of life for patients with advanced gastrointestinal cancer randomised to early specialised home-based palliative care: the ALLAN trial. Br J Cancer. 2024 Sep;131(4):729-736. doi: 10.1038/s41416-024-02764-x. Epub 2024 Jul 1.

  PMID: 38951699 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Depression; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases; Behavioral Symptoms; Behavior

Study Officials

• Mikael Segerlantz, MD, PhD

  Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: October 1, 2014
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

SE (1)