NCT00849979

Brief Summary

The goal of this study is to learn more about the symptoms that may occur in patients with GI cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas, colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

February 23, 2009

Last Update Submit

July 26, 2012

Conditions

Keywords

ColorectalGastricGastrointestinalGILiverPancreasGastrointestinal CancersGastro-Intestinal ChemotherapyM.D. Anderson Symptom InventoryMDASI-GIMedical Oncology

Outcome Measures

Primary Outcomes (1)

  • Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response)

    2 Years

Study Arms (2)

Questionnaire

OTHER
Behavioral: Questionnaire

Questionnaire + Interview

OTHER
Behavioral: QuestionnaireOther: Interview

Interventions

QuestionnaireBEHAVIORAL

Day 1 MDASI-GI Questionnaire

QuestionnaireQuestionnaire + Interview

Open-ended, audiotaped interviews

Questionnaire + Interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be out-patients being reviewed or treated in M. D. Anderson's Department of GI Medical Oncology.
  • Patients will have received a confirmed pathological diagnosis of GI cancer (gastric cancer, liver cancer, pancreatic cancer, colorectal cancer).
  • Patients will or will not be undergoing chemotherapy or treatment with other agents on the day of enrollment.
  • Patients must be \> or = 18 years of age.
  • Patients must be able to speak and read English.

You may not qualify if:

  • Patients who, in research staff's estimation, cannot understand the intent of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Xin Shelley Wang, MD, MPH

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

July 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations