Connecting Families to Overcome Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT04927013
• Recruitment Status: Recruiting
• First Posted: June 15, 2021
• Last Update Posted: October 19, 2022
• Sponsor: Emory University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Colleen McBride, Emory University

Tracking Information

• First Submitted Date: June 14, 2021
• First Posted Date: June 15, 2021
• Last Update Posted Date: October 19, 2022
• Actual Study Start Date: July 24, 2021
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2021)

• Proportion of Survivors Accessing the Website [ Time Frame: Up to 31 months ]
  Survivor reach is assessed as the proportion of the eligible survivors identified and contacted by GCR who log in to the website.
• Proportion of Relatives of Survivors Accessing the Website [ Time Frame: Up to 31 months ]
  Close relative reach is assessed as the proportion of close relatives enumerated by survivors who log in to the website.
• Proportion of Survivors Completing Telegenetic Counseling [ Time Frame: Up to 31 months ]
  Uptake of cancer genetic services will be assessed as the proportion of untested survivors who complete telegenetic counseling.
• Proportion of Relatives Completing Telegenetic Counseling [ Time Frame: Up to 31 months ]
  Uptake of cancer genetic services by relatives of survivors will be assessed as the proportion of relatives enumerated who complete the Breast Cancer Genetics Referral Screening Tool (B-RST) screening and subsequently access genetic counseling.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 14, 2021)

• Time Visiting Website by Survivors [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the duration of time (in minutes) that survivors spend on the website will be examined.
• Time Visiting Website by Relatives [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the duration of time (in minutes) that relatives of survivors spend on the website will be examined.
• Number of Return Visits to Website by Survivors [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the number of return visits to the website by survivors will be examined.
• Number of Return Visits to Website by Relatives [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the number of return visits to the website by relatives of survivors will be examined.
• Number of Pages Viewed by Survivors [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the number of website pages viewed by survivors will be examined.
• Number of Pages Viewed by Relatives [ Time Frame: Up to 31 months ]
  Among those in the intervention arm, the number of website pages viewed by relatives of survivors will be examined.
• Proportion Selecting Contact Options [ Time Frame: Up to 31 months ]
  The proportion of survivors in the intervention arm who select different relative contact options will be examined.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Connecting Families to Overcome Ovarian Cancer
• Official Title: Testing a Low Cost Population- and Theory-Based Outreach Intervention to Engage Ovarian Cancer Survivors and Their Close Relatives to Consider Genetic Services
• 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.

Detailed Description

The majority of women at greatest risk for ovarian cancer due to hereditary factors are unlikely to be aware of their elevated risk and available prevention options. Thus, most at-risk women are diagnosed when their ovarian cancer is advanced and treatment options are limited. Additionally, efforts to broaden awareness of genetic risk among at risk families has been very limited. State cancer registries' offer a potentially low cost platform for providing resources to ovarian cancer survivors and their close relatives.

In partnership with the Georgia Cancer Registry (GCR), the researchers are testing two different communication approaches to provide inherited risk information and free genetic counseling to ovarian cancer survivors and their close blood relatives. Participants will be assigned at random to visit one of two websites; those assigned to the "message-based" site will be offered assistance from the study team to contact close relatives and reminder messages and those viewing the other site will not. The researchers are testing which of the two approaches is most effective as indicated by: the number of survivors who visit the website; the number of close relatives who visit the website and the number of survivors and relatives who complete a genetic counseling session. The researchers hypothesize that the message-based approach will result in greater reach and uptake of genetic services than a standard approach.

The two outreach websites with content for both survivors and close relatives will be the hub in the wheel of intervention activity. In turn, the researchers will encourage access to the website using other communication channels as the spokes. The GCR will make initial contact with ovarian cancer survivors. The Registry will: 1) mail a packet of information about the study to identified survivors, and 2) make follow-up phone calls and send reminder postcards to encourage study participation. Survivors can then visit the assigned website and click a button indicating they agree to participate. Survivors assigned to the message-based intervention will receive additional short text messages encouraging them to contact relatives and seek genetic counseling. Relatives in this message-based group who choose to participate will also receive these short messages if they choose to provide contact information.

Free genetic counseling is being offered to participants in both study arms. The researchers are collaborating with Emory's Genetic Counseling Training program under the supervision of two certified genetic counselors. This study uses tele-medicine approaches to ensure access of survivors and relatives living in Georgia and elsewhere.

The results of the study could guide the development of outreach strategies for Georgia and other states to offer sustainable services to expand the reach of genetic services for ovarian and other heritable cancers.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Health Services Research
• Condition: Ovarian Cancer

Intervention

• Behavioral: Message-based Outreach Intervention for Survivors
  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.
• Behavioral: Standard Outreach for Survivors
  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.
• Behavioral: Message-based Outreach Intervention for Close Relatives
  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.
• Behavioral: Standard Outreach for Close Relatives
  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.

Study Arms

• Experimental: Message-based Outreach Intervention (MBI) for Survivors
  Cancer survivors randomized to receive a targeted letter with a unique website log in, access to the expanded website, free genetic counseling, and short message service (SMS) reminders.
  Intervention: Behavioral: Message-based Outreach Intervention for Survivors
• Active Comparator: Standard Outreach for Survivors
  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.
  Intervention: Behavioral: Standard Outreach for Survivors
• Experimental: Message-based Outreach Intervention for Close Relatives
  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.
  Intervention: Behavioral: Message-based Outreach Intervention for Close Relatives
• Active Comparator: Standard Outreach for Close Relatives
  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.
  Intervention: Behavioral: Standard Outreach for Close Relatives

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 14, 2021): 1240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for Survivors:

• 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

Inclusion Criteria for Close Relatives:

• 25 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

Exclusion Criteria:

• none

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Colleen McBride, PhD; 404-727-8226; colleen.marie.mcbride@emory.edu

Contact: Yue Guan, PhD, MS; yue.guan@emory.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04927013
• Other Study ID Numbers: STUDY00000224; 1U01CA240581 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data collected during the trial will be available for sharing, after de-identification.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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.

• Current Responsible Party: Colleen McBride, Emory University
• Original Responsible Party: Same as current
• Current Study Sponsor: Emory University
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Colleen McBride, PhD; Emory University

• PRS Account: Emory University
• Verification Date: October 2022