Connecting Families to Overcome Ovarian Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927013
• Other study ID #: STUDY00000224
• Secondary ID: 1U01CA240581
• Status: Completed
• Phase: N/A
• Start date: July 24, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Survivors Accessing the Website	Survivor reach is assessed as the proportion of the eligible survivors identified and contacted by GCR who log in to the website.	Up to 31 months
Primary	Proportion of Relatives of Survivors Accessing the Website	Close relative reach is assessed as the proportion of close relatives enumerated by survivors who log in to the website.	Up to 31 months
Primary	Proportion of Survivors Completing Telegenetic Counseling	Uptake of cancer genetic services will be assessed as the proportion of untested survivors who complete telegenetic counseling.	Up to 31 months
Primary	Proportion of Relatives Completing Telegenetic Counseling	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.	Up to 31 months
Secondary	Time Visiting Website by Survivors	Among those in the intervention arm, the duration of time (in minutes) that survivors spend on the website will be examined.	Up to 31 months
Secondary	Time Visiting Website by Relatives	Among those in the intervention arm, the duration of time (in minutes) that relatives of survivors spend on the website will be examined.	Up to 31 months
Secondary	Number of Return Visits to Website by Survivors	Among those in the intervention arm, the number of return visits to the website by survivors will be examined.	Up to 31 months
Secondary	Number of Return Visits to Website by Relatives	Among those in the intervention arm, the number of return visits to the website by relatives of survivors will be examined.	Up to 31 months
Secondary	Number of Pages Viewed by Survivors	Among those in the intervention arm, the number of website pages viewed by survivors will be examined.	Up to 31 months
Secondary	Number of Pages Viewed by Relatives	Among those in the intervention arm, the number of website pages viewed by relatives of survivors will be examined.	Up to 31 months
Secondary	Proportion Selecting Contact Options	The proportion of survivors in the intervention arm who select different relative contact options will be examined.	Up to 31 months