Trial record 2 of 14 for:    secure registry

Web-Based Family Outreach Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02337452
First received: January 9, 2015
Last updated: April 10, 2015
Last verified: April 2015
  Purpose

The goals of this study is to create a web-based program that can improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks. Researchers would also like to build a database for future research.


Condition Intervention
Advanced Cancers
Anal Cancer
Colorectal Cancer
Gastrointestinal Cancer
Behavioral: Family History Questionnaire
Behavioral: Web-Based Family Outreach Registry

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration: 9999 Years
Official Title: The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Web-based Family Outreach Registry [ Time Frame: Continual assessment of data over unlimited time frame ] [ Designated as safety issue: No ]
    Data analysis for core functions of the web-based Family Outreach Registry will generally be descriptive. Web-based program to improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks.


Estimated Enrollment: 10000
Study Start Date: April 2015
Estimated Primary Completion Date: April 2048 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Relative of MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Non-MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants with genetic abnormalities and their families at MD Anderson Cancer Center in Houston, Texas

Criteria

Inclusion Criteria:

  1. Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry.
  2. Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in FAP, or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC).
  3. At-risk family members (older than 18 years of age) of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this, as outlined below in section 4.0 Research Plan and Methods.

Exclusion Criteria:

  1. Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available.
  2. Patients who are unwilling or are unable to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02337452

Contacts
Contact: Patrick Lynch, MD, JD 713-794-5073

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Patrick Lynch, MD, JD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02337452     History of Changes
Other Study ID Numbers: 2014-0715
Study First Received: January 9, 2015
Last Updated: April 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hereditary cancer-causing mutation
Gene mutation
Family member with genetic mutation
Questionnaire
Surveys
Registry
Database
Communication

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 23, 2015