Connecting Families to Overcome Ovarian Cancer

Emory University

Status: Completed

Conditions: Ovarian Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04927013

STUDY00000224

1U01CA240581 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,331 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,331 participants in 4 patient groups

Message-based Outreach Intervention (MBI) for Survivors

Experimental group

Description:

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.

Treatment:

Behavioral: Message-based Outreach Intervention for Survivors

Standard Outreach for Survivors

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Outreach for Survivors

Message-based Outreach Intervention for Close Relatives

Experimental group

Description:

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.

Treatment:

Behavioral: Message-based Outreach Intervention for Close Relatives

Standard Outreach for Close Relatives

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Outreach for Close Relatives