Swedish Esophageal and Cardia Cancer Study

NCT ID: NCT06031155

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 616 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2025-12-31

Brief Summary

The overall objective of this nationwide Swedish project is to identify strategies that can help reduce the suffering and improve the survivorship among patients surgically treated for oesophageal cancer. This objective can be accomplished by a broad research approach that aims to:

1. describe health-related quality of life (HRQL)

2. identify risk factors and preventive actions for poor HRQL

Detailed Description

This is a Swedish nationwide, prospective, and population-based cohort including 90% of all patients operated on for esophageal or gastroesophageal junctional cancer in Sweden between 1st April 2001 and 31st December 2005. Detailed clinical data were continuously collected from medical records based on a predefined study protocol to ensure uniformity. The clinical data collected included patient and tumor characteristics, treatment details, and follow-up on complications. Patients were followed up with health-related quality of life (HRQL) questionnaires. The core questionnaire (EORTC QLQ-C30) was used to measure aspects of HRQL and symptoms that are applicable for cancer patient in general, whereas the esophageal cancer-specific module (EORTC QLQ-OES18) measured symptoms common among esophageal cancer patients. HRQL was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year follow-up is ongoing. All questionnaires were self-administered, delivered by mail and up to three reminders were sent if required. Collection of HRQL data was obtained anonymously (patients sent their answers to a central administration and not to the treating department). The all-cause and disease-specific mortality was assessed by linkage to the Causes of Death Registry. Informed consent was obtained from each participant.

Conditions

Oesophageal Cancer; Surgery; Survivorship; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients who are alive and able to participate in the project 6 months following surgery for oesophageal cancer are eligible to participate in the study.

Exclusion Criteria

• Patients with cognitive impairment, who are unable to complete the measures in Swedish or are too unwell to complete the assessment, are excluded from the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Jesper Lagergren

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pernilla Lagergren, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Other Identifiers

SECC

Identifier Type: -

Identifier Source: org_study_id