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Quality of Life After Oesophageal or Gastric Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Region Skane
Sponsor:
Collaborator:
Skåne University Hospital
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01657175
First received: June 29, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Quality of Life
Oesophageal Cancer
Gastric Cancer
Other: Supportive care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Satisfaction with care [ Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge. ] [ Designated as safety issue: No ]

    Satisfaction with care is evaluated using EORTC satisfaction with care instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.

    Discharge: approximately 2-4 weeks after surgery


  • Informational need [ Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge. ] [ Designated as safety issue: No ]

    Informational needs is evaluated using EORTC INFO 25 instrument, at discharge and 2 weeks, 2,4 and 6 months after discharge.

    Discharge: approximately 2-4 weeks after surgery


  • sense of coherence (KASAM) [ Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge. ] [ Designated as safety issue: No ]

    KASAM is evaluated using the KASAM instrument, at discharge and 2 weeks, 2,4 and 6 months after discharge.

    Discharge: approximately 2-4 weeks after surgery


  • Contacts with the health care system [ Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge. ] [ Designated as safety issue: No ]

    Contacts with the health care system is evaluated through a diary at the time for the discharge and 2 weeks, 2,4 and 6 months after discharge.

    Discharge: approximately 2-4 weeks after surgery



Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care
The patients randomized to the supportive care arm get an extended supportive care during the first year after surgery.
Other: Supportive care

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
No Intervention: Control
The patients randomized to the control group get "care as usual"

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657175

Contacts
Contact: Marlene Malmström, RN PhD-student +46 46 175950 marlene.malmstrom@ed.lu.se

Locations
Sweden
Skåne University Hospital Recruiting
Lund, Sweden, 22185
Contact: Marlene Malmström, RN, Phd-Student    +46 46 175950    marlene.malmstrom@ed.lu.se   
Sponsors and Collaborators
Region Skane
Skåne University Hospital
Investigators
Study Director: Jan Johansson, MD PHD Department of surgery, Skåne university hospital
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01657175     History of Changes
Other Study ID Numbers: 2009 /117
Study First Received: June 29, 2012
Last Updated: July 5, 2013
Health Authority: Sweden: Skåne University hospital

Keywords provided by Region Skane:
Cancer
long-term follow-up
quality of life
Surgery
Nursing

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 28, 2014