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Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508846
First received: July 26, 2007
Last updated: September 26, 2012
Last verified: September 2012
History of Changes

July 26, 2007
September 26, 2012
May 2003
May 2014   (final data collection date for primary outcome measure)
Patient Responses to Questionnaire [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.
Not Provided
Complete list of historical versions of study NCT00508846 on ClinicalTrials.gov Archive Site
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Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients
Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)

Among women with HNPCC, this study will assess:

  1. Knowledge of screening recommendations for endometrial and ovarian cancers.
  2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
  3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.
  4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
  5. Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
  6. Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.

Women who are at risk for HNPCC will be recruited to participate in this pilot study.

Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.

Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).
Colon Cancer
Behavioral: Questionnaire
Two-part telephone questionnaire lasting about 60 minutes total.
Other Name: Survey
HNPCC Patients
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
95
Not Provided
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Being female
  2. Being 25 years of age or older
  3. Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC

Exclusion Criteria:

  1. Persons who have tested negative for a known HNPCC-predisposing mutation in their family
  2. Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
  3. Being younger than 25 years old
  4. Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508846
ID03-0211
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Susan Peterson, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2012

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