Quality of Life Among Long-Term Survivors of Resected Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Quality of Life Among Long-Term Survivors of Resected Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598546
• Other study ID #: 04-112
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: July 9, 2009
• Start date: September 2004
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to find out how you feel about the quality of your life after having had surgery to remove your stomach tumor. Some patients continue to experience different problems after stomach surgery, even when the surgery was more than three years ago. The purpose of this study is to find out the specific things that may continue to affect patients' quality of life after a major operation.

Description:

The purpose of this study is to measure the quality of life (QOL) of long-term survivors of resected gastric cancer. This cohort of long-term survivors will include patients who have no evidence of disease (NED) at least three years after having curative resection for gastric cancer. There are three main types of surgical procedures used to resect primary gastric cancer, which include proximal subtotal, distal subtotal, and total gastrectomy. Surgical management of gastric cancer at Memorial Sloan-Kettering Cancer Center (MSKCC) has shifted over the years to a greater use of proximal subtotal gastrectomies than in the past; however the effects on the QOL of these patients are unknown. In this study, we propose to use the European Organization for Research Treatment of Cancer (EORTC) two-part questionnaire QLQ-C30 and QLQ-STO22. This instrument has been shown to be a valid and reliable QOL instrument used to assess the quality of life of patients with gastric cancer.

We will measure multiple domains of QOL including, physical, role, cognitive, and emotional functions. An additional 10-item questionnaire (MSK-10) was designed by GMT service surgeons and will be administered in order to more specifically identify certain potential issues of QOL among gastric cancer survivors. These issues include eating capabilities, work status and major life changing events. Patients will be identified using the Gastric and Mixed Tumor (GMT) Service Gastric Cancer Database. The questionnaires will be conducted via telephone interview. Establishing these QOL measurements will help to provide valuable baseline data upon which to base future clinical trials of optimal surgical techniques.

OBJECTIVES AND SCIENTIFIC AIMS

• To establish health related QOL using the EORTC QLQ-C30 and QLQ-STO22 in gastric cancer patients who are alive and free of disease for three or more years after a proximal, distal, or total gastrectomy for gastric cancer.

• To compare the differences in QOL scores between the three different types of gastrectomy.

• To compare results using the EORTC QLQ-C30 with published norms established in the United States.

• To use the MSK-10 to assess the incidence and degree of certain areas of QOL that may affect gastric cancer survivors specifically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients

• Age 18 or older

• Diagnosis of adenocarcinoma of the stomach

• Patient had curative surgical resection, including proximal, distal, or total gastrectomy

• Patient is at least three years NED

• Provide informed consent

• Fluent in English

Exclusion Criteria:

• Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires

• Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• EORTC QLQ-C30, QLQ-STO22, and MSK-10
QLQ-C30 is the generic QOL tool for patients with cancer undergoing clinical trials.QLQ-STO22, containing 22 questions specific to gastric cancer, is currently the only standardized disease-specific questionnaire to measure the QOL of gastric cancer and must be used in conjunction with the QLQ-C30.MSK-10 consists of ten additional questions that were developed by surgeons on the GMT service to answer specific questions about outcomes related to proximal subtotal, distal subtotal, and total gastrectomies. These questions focus on eating capabilities, work status and major life changing events.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instrument: EORTC QLQ-C30, QLQ-STO22, and MSK-10. The intent of this study is to assess QOL in long-term survivors of all surgical procedures performed for the treatment of gastric cancer.		5 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center