Swedish Esophageal and Cardia Cancer Study (SECC)

September 3, 2023 updated by: Jesper Lagergren, Karolinska Institutet

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:

describe health-related quality of life (HRQL)
identify risk factors and preventive actions for poor HRQL

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

616

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General health-related quality of life (HRQL) Time Frame: 6 months, 3, 5, 10,15 and 20 years	The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This 30-item cancer-specific questionnaire includes one global quality of life scale, five functional scales (physical, role, emotional, cognitive, and social function), three symptom scales (fatigue, nausea, and pain), and six single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire scores were transformed into 0-100 scales. Higher scores in the global quality of life scale, functional scales, and HRQL summary score represent better HRQL or function, while higher scores in the symptom scales or items correspond to more symptoms. Missing data were handled according to the EORTC scoring manual.	6 months, 3, 5, 10,15 and 20 years
Disease specific health-related quality of life (HRQL) Time Frame: 6 months, 3, 5, 10,15 and 20 years	The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Oesophageal Cancer Module 18 questionnaire (EORTC QLQ-OES18). This is an 18-item well-validated questionnaire measuring esophageal cancer-specific symptoms. It comprises four multi-item scales (dysphagia, eating difficulties, reflux, and pain) and six single items (trouble swallowing saliva, choking when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking). The response alternatives make up a four-point Likert scale: [1] 'Not at all', [2] 'A little', [3] 'Quite a bit' and [4] 'Very much'. The responses were transformed into a score within the range of 0-100. High scores in scales and single items represent high level of symptoms. Missing data were handled according to the EORTC scoring manual.	6 months, 3, 5, 10,15 and 20 years

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

Principal Investigator: Pernilla Lagergren, PhD, Karolinska Institutet

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 (Actual)

April 1, 2001

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)