Clinical trial NCT04927013: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Genetic counseling
Risk assessment
Family communication
Genetic risk communication
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-15
Enrollment: 2331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Survivors Using Website Access Code
timeFrame: Up to 19 months
measure: Number of Survivors Consenting to Participate in the Study
timeFrame: Up to 19 months
measure: Number of Survivors Creating a Study Login
timeFrame: Up to 19 months
measure: Number of Relatives of Survivors Using the Website Access Code
timeFrame: Up to 19 months
measure: Number of Relatives of Survivors Consenting to Participate in the Study
timeFrame: Up to 19 months
measure: Number of Relatives of Survivors Creating a Login
timeFrame: Up to 19 months
Secondary outcomes:
measure: Relative Contact Option Selected by Survivors
timeFrame: Up to 19 months
measure: Number of Survivors Requesting Telegenetic Counseling
timeFrame: Up to 19 months
measure: Number of Survivors Completing Telegenetic Counseling
timeFrame: Up to 19 months
measure: Number of Relatives Requesting Telegenetic Counseling
timeFrame: Up to 19 months
measure: Number of Relatives Completing Telegenetic Counseling
timeFrame: Up to 19 months
measure: Time Visiting Website by Survivors
timeFrame: Up to 19 months
measure: Time Visiting Website by Relatives
timeFrame: Up to 19 months
measure: Number of Return Visits to Website by Survivors
timeFrame: Up to 19 months
measure: Number of Return Visits to Website by Relatives
timeFrame: Up to 19 months
measure: Number of Pages Viewed by Survivors
timeFrame: Up to 19 months
measure: Number of Pages Viewed by Relatives
timeFrame: Up to 19 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen McBride, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.