Connecting Families to Overcome Ovarian Cancer

NCT04927013 | Completed Results

• 2 other identifiers: STUDY000002241U01CA240581
• Study Type: interventional
• Target: 2,331
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests a multi-component, low cost, message-based communication outreach intervention to engage ovarian cancer survivors and their at-risk relatives in considering cancer genetic services. The intervention includes foot-in-the-door techniques, tailored/targeted print, website support, and short messages to expand reach of prevention messages.

Conditions

Ovarian Cancer

Keywords

Genetic counseling; Risk assessment; Family communication; Genetic risk communication

Outcome Measures

Primary Outcomes (6)

• Number of Survivors Using Website Access Code

  Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who used their unique login to access the study website.

  Up to 19 months

• Number of Survivors Consenting to Participate in the Study

  Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who used their unique login code to access the study website and consented to participate in the study while visiting the website.

  Up to 19 months

• Number of Survivors Creating a Study Login

  Survivor reach is assessed as the number of the eligible survivors identified and contacted by GCR who access the study website, consented to participate in the study, and created their own personal study login on the website.

  Up to 19 months

• Number of Relatives of Survivors Using the Website Access Code

  Close relative reach is assessed as the number of close relatives enumerated by survivors who used their unique login code to access the study website.

  Up to 19 months

• Number of Relatives of Survivors Consenting to Participate in the Study

  Close relative reach is assessed as the number of close relatives enumerated by survivors who accessed the website and consented to participate in the study while they were using the website.

  Up to 19 months

• Number of Relatives of Survivors Creating a Login

  Close relative reach is assessed as the number of close relatives enumerated by survivors who accessed the study website, gave consent to participate in the study, and created their own personal study login on the study website.

  Up to 19 months

Secondary Outcomes (11)

• Relative Contact Option Selected by Survivors

  Up to 19 months

• Number of Survivors Requesting Telegenetic Counseling

  Up to 19 months

• Number of Survivors Completing Telegenetic Counseling

  Up to 19 months

• Number of Relatives Requesting Telegenetic Counseling

  Up to 19 months

• Number of Relatives Completing Telegenetic Counseling

  Up to 19 months

Study Arms (4)

Message-based Outreach Intervention (MBI) for Survivors

EXPERIMENTAL

Cancer survivors randomized to receive a targeted letter with a unique website login code, access to the expanded website, free genetic counseling, and short message service (SMS) reminders.

Behavioral: Message-based Outreach Intervention for Survivors

Standard Outreach for Survivors

ACTIVE COMPARATOR

Cancer survivors randomized to receive the standard outreach consisting of a standard letter with website access, access to a condensed version of the study website, and free genetic counseling.

Behavioral: Standard Outreach for Survivors

Message-based Outreach Intervention for Close Relatives

EXPERIMENTAL

Close relatives of cancer survivors who were randomized to receive the message-based outreach. Close relatives will have access to the expanded version of the study website and free genetic counseling.

Behavioral: Message-based Outreach Intervention for Close Relatives

Standard Outreach for Close Relatives

ACTIVE COMPARATOR

Close relatives of cancer survivors who were randomized to receive the standard outreach. Close relatives will have access to a condensed version of the study website and free genetic counseling.

Behavioral: Standard Outreach for Close Relatives

Interventions

Message-based Outreach Intervention for Survivors BEHAVIORAL

The Georgia Cancer Registry will mail the initial recruitment containing messages intended to persuade the survivor to visit the study website as well as a unique login to access the website. In addition to the components of the standard website, an expanded website for the Message-based group will include Guidance for Talking with Close Relatives about Their Cancer Risk, and the request to enumerate each close relative and choose from a menu of options about how the survivor would prefer for their relatives to be contacted. Survivors also can select the option that they prefer a relative not be contacted. In this case, no invitation letter will be generated for these relatives. Survivors who provide mobile phone numbers will receive two SMS thanking them for accessing the website, and encouraging them to revisit the website to review information and contact relatives. The messages will occur at 3-week intervals over a 6-week time period.

Message-based Outreach Intervention (MBI) for Survivors

Standard Outreach for Survivors BEHAVIORAL

The Georgia Cancer Registry will mail survivors an introductory letter modeled on the Registry's general outreach letters that will include log in information. Survivors will have access to a condensed version of the website that includes Information about Ovarian Cancer, Information about Who in Your Family is at Increased Risk, and the offer of Free Genetic Counseling with the option to schedule an appointment.

Standard Outreach for Survivors

Message-based Outreach Intervention for Close Relatives BEHAVIORAL

Relatives will receive a unique website login linked to the survivor that enables access to the website. The website content will be identical to the survivor content with the exception of the addition of the Breast Cancer Genetics Referral Screening Tool (B-RST) risk assessment tool. This brief risk assessment is a validated screening tools that is clinically useful for estimating the probability of breast cancer (BRCA1/2) gene mutation and identifying women for referral to genetic counseling. Although all 1st or 2nd degree relatives of ovarian cancer survivors will screen positive on B-RST, asking relatives to complete the screener aims to raise their awareness of the factors that contribute to hereditary risk of ovarian cancer and will reinforce the salience of seeking genetic counseling. Additionally, relatives for who provide cell phone numbers will receive 3 SMS reminders over 9 weeks.

Message-based Outreach Intervention for Close Relatives

Standard Outreach for Close Relatives BEHAVIORAL

The invitation letter shared by the survivor will provide a unique login code for each relative to visit the standard website with sections specifically for relatives that include information about genetic risk, the value of completing an online short validated risk screener, and the offer of free genetic counseling with the option to schedule an appointment.

Standard Outreach for Close Relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• in the Georgia Cancer Registry (GSR)
• diagnosed with ovarian, fallopian tube, or peritoneal cancers
• lived in Georgia at the time of diagnosis
• not deceased per the registry's records
• have a mailing address in GSR records
• years or older
• able to access the internet
• a 1st or 2nd degree relative of the survivor
• able to read English
• non-incarcerated or institutionalized

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Guan Y, McBride CM, Zhao J, Pentz RD, Escoffery C, Liu Y, Cao Y, An W, Shepperd JA, Ward KC. Testing a Population-Based Outreach Intervention for Ovarian Cancer Survivors to Encourage their Close Relatives to Consider Genetic Counseling. Cancer Epidemiol Biomarkers Prev. 2024 Sep 3;33(9):1185-1193. doi: 10.1158/1055-9965.EPI-24-0147.

  PMID: 38912902 RESULT

• Shepperd JA, McBride CM, An W, Zhao J, Pentz RD, Escoffery C, Ward K, Guan Y. Trust and Privacy Concerns Among Cancer Survivors Who Did Not Visit a Research Website Offering Free Genetic Counseling Services for Families: Survey Study. J Med Internet Res. 2025 May 6;27:e64228. doi: 10.2196/64228.

  PMID: 40327861 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Yue Guan, PhD
• Organization: Emory University

yue.guan@emory.edu

404-712-1671

Study Officials

• Colleen McBride, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 15, 2021
• Study Start: July 24, 2021
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for sharing immediately following the publication and release of the key manuscripts tied to the primary aims of this study, and ending approximately 18 months after funding ends.
• Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims stated in the approved proposal. Proposals should be directed to Dr. Colleen McBride at colleen.marie.mcbride@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)