Quality of Life After Oesophageal or Gastric Cancer Surgery

NCT01657175 | Completed

• 1 other identifier: 2009 /117
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim 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 quality of life (QOL) after surgery. The project contains 3 part-studies focusing on the patients life after surgery. Data will be collected through focus group interviews and a randomized controlled trial (RCT) study.

Conditions

Quality of Life; Oesophageal Cancer; Gastric Cancer

Keywords

Cancer; long-term follow-up; quality of life; Surgery; Nursing

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  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.

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

Secondary Outcomes (4)

• Satisfaction with care

  At dischage, 2 weeks, 2, 4 and 6 months after discharge.

• Informational need

  At dischage, 2 weeks, 2, 4 and 6 months after discharge.

• sense of coherence (KASAM)

  At dischage, 2 weeks, 2, 4 and 6 months after discharge.

• Contacts with the health care system

  At dischage, 2 weeks, 2, 4 and 6 months after discharge.

Study Arms (2)

Supportive care

EXPERIMENTAL

The patients randomized to the supportive care arm get an extended supportive care during the first year after surgery.

Other: Supportive care

Control

NO INTERVENTION

The patients randomized to the control group get "care as usual"

Interventions

Supportive care OTHER

The patients will be randomized to control or supportive care groups. The control group will be given "care as usual" wich include clinical follow-ups at the surgical department. The supportive care group get in addition to the clinical follow-ups a supportive care programme including: * Discharge information about surgery and life after surgery together with their relatives. * Active telephone contacts 1/week th first month the 2/month up to six month after discharge by a specialized nurs. * Open telephone line were the patients can call the nursed ruing daytime. Discharge: approximately 2-4 weeks after surgery

Supportive care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Skane University Hospital: collaborator

Study Sites (1)

Skåne University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jan Johansson, MD PHD

  Department of surgery, Skåne university hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: August 6, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)