NCT00598546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

January 10, 2008

Last Update Submit

July 9, 2009

Conditions

Keywords

StomachGastricStomach TumorStomach Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

Behavioral: EORTC QLQ-C30, QLQ-STO22, and MSK-10

Interventions

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had curative resection at MSKCC for gastric cancer and are at least three years NED.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Daniel Coit, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 22, 2008

Study Start

September 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations