Connecting Families to Overcome Ovarian Cancer

Not Applicable

Completed

Conditions: Ovarian Cancer

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

Registration Number: NCT04927013

Lead Sponsor: Emory University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2331

Inclusion Criteria

Not provided

Exclusion Criteria

none

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Message-based Outreach Intervention (MBI) for Survivors	Message-based Outreach Intervention for Survivors	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.
Standard Outreach for Survivors	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.
Message-based Outreach Intervention for Close Relatives	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.
Standard Outreach for Close Relatives	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.

Primary Outcome Measures

Name	Time	Method
Number of Survivors Using Website Access Code	Up to 19 months	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.
Number of Survivors Consenting to Participate in the Study	Up to 19 months	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.
Number of Survivors Creating a Study Login	Up to 19 months	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.
Number of Relatives of Survivors Using the Website Access Code	Up to 19 months	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.
Number of Relatives of Survivors Consenting to Participate in the Study	Up to 19 months	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.
Number of Relatives of Survivors Creating a Login	Up to 19 months	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.

Secondary Outcome Measures

Name	Time	Method
Relative Contact Option Selected by Survivors	Up to 19 months	Cancer survivors in the Message-based Outreach Intervention arm who accessed the website were asked to enumerate close relatives and choose from a menu of options about how the survivor would prefer for their relatives to be contacted.
Number of Survivors Requesting Telegenetic Counseling	Up to 19 months	The request rate of cancer genetic services is assessed as the number of cancer survivors who requested telegenetic counseling on the website.
Number of Survivors Completing Telegenetic Counseling	Up to 19 months	Uptake of cancer genetic services is assessed as the number of survivors who completed telegenetic counseling.
Number of Relatives Requesting Telegenetic Counseling	Up to 19 months	The request rate of cancer genetic services is assessed as the number of close relatives who requested telegenetic counseling on the website.
Number of Relatives Completing Telegenetic Counseling	Up to 19 months	Uptake of cancer genetic services by relatives of survivors is assessed as the number of relatives enumerated who completed the Breast Cancer Genetics Referral Screening Tool (B-RST) screening and subsequently accessed genetic counseling.
Time Visiting Website by Survivors	Up to 19 months	The duration of time (in minutes) that survivors in the Message-based Outreach Intervention (MBI) study arm spent on the website was examined.
Time Visiting Website by Relatives	Up to 19 months	Among those in the intervention arm, the duration of time (in minutes) that relatives of survivors spend on the website was examined.
Number of Return Visits to Website by Survivors	Up to 19 months	The number of return visits to the website by survivors in the MBI study arm was examined.
Number of Return Visits to Website by Relatives	Up to 19 months	Among those in the intervention arm, the number of return visits to the website by relatives of survivors was examined.
Number of Pages Viewed by Survivors	Up to 19 months	The number of website page viewed by survivors in the MBI study arm was examined.
Number of Pages Viewed by Relatives	Up to 19 months	Among those in the intervention arm, the number of website pages viewed by relatives of survivors will be examined.