Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

This trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become aware of their risks.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Web Site

Detailed Description

PRIMARY OBJECTIVES:

I. To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).

II. The long-term goals of this program are expected to include, but are not limited to the following:

IIa. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program.

IIb. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal.

IIc. To facilitate genetic testing, screening and prevention strategies in those at risk.

IId. Establish high-risk cohort for optional participation in research and clinical trials.

OUTLINE:

Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow-up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

• Study Contact: Name: Patrick M Lynch; Phone Number: 713-794-5073; Email: plynch@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

• 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
• 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 familial adenomatous polyposis [FAP], or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC)
• At-risk family members 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.

Exclusion Criteria:

• 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
• Patients who are unwilling or are unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (family outreach program); Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.

Other: Questionnaire Administration; Ancillary studies; Behavioral: Web Site; Communicate via family outreach program website; Other Names: Internet Website; Website; www-website

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Web-Based Family Outreach Registry	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.	Continual assessment of data over participant's life time (target follow-up duration: 40 Years)

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Selvi Thirumurthi, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2015
• Primary Completion (Estimated): April 30, 2048
• Study Completion (Estimated): April 30, 2048

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimated): January 13, 2015

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2014-0715 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2020-00567 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No