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Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.

18 Years
Open (Enrolling)
Quality of Life, Oesophageal Cancer, Gastric Cancer

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Trial Information

Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.


Patients who have undergone oesophageal resections for cancer have shown reduced quality of
life (QOL) during substantial time after surgery. Postoperatively, patients are faced with
extensive changes in their daily life including reduced physical and sometimes psychological
capacities, problems that may be underestimated by the health care providers.

Worldwide oesophageal cancer is the 8th and gastric cancer the 4th most common cancer
diagnoses (National Board of Health and Welfare, 2009). In 2009 in Sweden there were 443 new
cases of oesophageal cancer and 882 of gastric cancer (total number of inhabitants in 2009,
9.4 million). Surgery, alone or in combination with chemotherapy or radiotherapy, is the
only established treatment and thus offers the only possibility of a cure. After
oesophagectomy or gastrectomy the planned hospital stay is approximately two to three weeks,
and the expected recovery period is at least one year. The prolonged recovery period is
pointed out as an energy-requiring process including physiological, psychological, social
and habitual recovery, which increases the challenges for this group of patients after
surgery. Even though survival after surgery, for both oesophageal and gastric cancer, has
gradually improved, the 5-year survival rate remains at only 28% respectively 27%.


The aim of this project is to assess quality of life of patients 0-5 years after oesophageal
or gastric cancer surgery and to develop and test an information and support program aiming
to enhance the patients QOL after surgery.

The project contains 3 part-studies that focus on the patients life after surgery.


In both studies patients that when through oesophagectomy or gastrectomy due to cancer is
included. Patients that has suffered a relapse of their cancer disease, are unable to
communicate in Swedish or has went through a acute surgery is not included.

Study I and II:

This studies is carried out in accordance with a descriptive explorative design focusing on
I: The patients subjective experience of their QOL and II: The patients´ experience and need
of supportive care, after surgery for oesophageal/gastric cancer. Data collection is carried
out using semi-structured focus group interviews. A total of 17 participants divided into 4
focus groups are included (2-5 years after elective surgery) in the study. Data are to be
analysed with qualitative content analysis focusing on the patients experiences of their
supportive care needs after surgery.

Study III:

This study is a randomized controlled trial that focus on testing a information and support
programme to patients after oesophagectomy or gastrectomy due to cancer. The intervention
group gets support from a specialized nurse after surgery which contacts the patients
according to a given interval during the follow up period (6 months). The control group
follows the regular follow up programme that are used at the hospital where the study is

The information and support programme are evaluated through validated questionnaires that
focus on quality of life (EORTC QLQ-C30 and OES-18), satisfaction whit care (EORTC
INPATSAT32), sense of coherence (KASAM) and information needs (EORTC INFO 25). The patients
also writes a diary regarding health care contacts after surgery.

A total number of 80 are patients are planed to be included in the study.

Inclusion Criteria:

- Patients with any stage tumours in the distal third of the oesophagus including type
II tumours at the gastro-oesophageal junction

- Transthoracic oesophageal resection with gastric tube reconstructions and circular
stapled anastomoses in the upper right chest Postoperative clinical courses without
complications, and postoperative anastomotic radiograms without anastomotic leakage

- Macro and microscopically tumour free upper resection margins Willingness, physical
and mental capability to comply with the result of the randomization, and ability to
follow the study protocol

- Adult >18 years

- Living in the southern of Sweden (Skåne county)

Exclusion Criteria:

- Preoperative or planned postoperative chemotherapy or radiotherapy to the tumour area
known at the time of discharge from the hospital.

- Postoperative need for continuous treatment with proton pump inhibitors (PPIs) or
histamine-2 blockers. Treatment with steroidal or non steroidal anti inflammatory
drugs other than occasionally

- Known allergy or side effects to PPIs preventing continuous treatment for one year

- Present drug or alcohol abuse

- Failure to attend at least one postoperative visit

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Outcome Measure:

Quality of Life

Outcome Description:

Quality of life will be measured at discharge, 2 weeks, 2, 4 and 6 months after discharge (discharge= approximately 2-4 weeks after surgery). Quality of life is evaluated using EORTC quality of life instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.

Outcome Time Frame:

Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge

Safety Issue:


Principal Investigator

Jan Johansson, MD PHD

Investigator Role:

Study Director

Investigator Affiliation:

Department of surgery, Skåne university hospital


Sweden: Skåne University hospital

Study ID:

2009 /117



Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Quality of Life
  • Oesophageal Cancer
  • Gastric Cancer
  • Cancer
  • long-term follow-up
  • quality of life
  • Surgery
  • Nursing
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms