Clinical trial NCT06031155: Swedish Esophageal and Cardia Cancer Study
Official title: Swedish Esophageal and Cardia Cancer Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Oesophageal Cancer
Surgery
Survivorship
Quality of Life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 616
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included patients having been curatively treated, including surgical resection (esophagectomy), for esophageal or gastroesophageal junctional cancer (adenocarcinoma or squamous cell carcinoma) between April 2, 2001 and December 31, 2005.

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.

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.

Primary outcomes:
measure: General health-related quality of life (HRQL)
timeFrame: 6 months, 3, 5, 10,15 and 20 years
measure: Disease specific health-related quality of life (HRQL)
timeFrame: 6 months, 3, 5, 10,15 and 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Lagergren, PhD
role: PRINCIPAL_INVESTIGATOR
References: