Surgical Decision Making Among People With Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00438711
First received: February 20, 2007
Last updated: July 19, 2011
Last verified: July 2011

February 20, 2007
July 19, 2011
September 2005
December 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00438711 on ClinicalTrials.gov Archive Site
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Surgical Decision Making Among People With Inflammatory Bowel Disease
Surgical Decision Making Among People With Inflammatory Bowel Disease

This is a study for people with inflammatory bowel disease ("IBD"--that is, ulcerative colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD decide to have surgery when a doctor has told them they should think about having their colon (large bowel) removed. This surgery is called a "colectomy." Patients will be asked to fill out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about patients' background (age, etc.) and their IBD. They also ask about patients' decision to have surgery or not to have surgery. For instance, what kinds of things did they think about? Some questions ask about other people who affected the choice and how patients felt about the help they got from others. People who wish to join the study will receive payment to thank them for their time.

  • Patients must be at least 18 years old
  • Patients must speak English
  • Patients must have been told by their doctor to think about having surgery to take out their colon to (a) lower their risk for cancer or (b) because they have pre-cancer (called "dysplasia")
  • Patients do not need to have had the surgery--they may have already had the surgery, they may not have had it yet, or they may have decided they do not want to have it
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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

People with inflammatory bowel disease who respond to advertisements and study announcements or who were treatment at the recruitment site and referred by their physician.

Inflammatory Bowel Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
  2. Be at least 18 years old
  3. Speak English
  4. Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438711
NCI K07 CA104701, GCO#03-0141, K07CA104701
No
Christine Rini, Ph.D., Research Assistant Professor, University of North Carolina at Chapel Hill
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Principal Investigator: Christine Rini, Ph.D. University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP