NCT00508846

Brief Summary

Among women with HNPCC, this study will assess:

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2003

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

May 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

12.8 years

First QC Date

July 26, 2007

Last Update Submit

March 10, 2016

Conditions

Keywords

Hereditary Non-Polyposis Colon CancerGynecologic CancersGenetic CounselingQuestionnaireSurveyHNPCC

Outcome Measures

Primary Outcomes (1)

  • Patient Responses to Questionnaire

    Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.

    7 Years

Study Arms (1)

HNPCC Patients

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Two-part telephone questionnaire lasting about 60 minutes total.

Also known as: Survey
HNPCC Patients

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).

You may qualify if:

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

You may not qualify if:

  • Persons who have tested negative for a known HNPCC-predisposing mutation in their family
  • Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
  • Being younger than 25 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic 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

  • Susan Peterson, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

May 1, 2003

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations