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


N/A
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Daniel Coit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-112

NCT ID:

NCT00598546

Start Date:

September 2004

Completion Date:

June 2009

Related Keywords:

  • Gastric Cancer
  • Stomach
  • Gastric
  • Stomach Tumor
  • Stomach Cancer
  • Stomach Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021