Trial Outcomes & Findings for Connecting Families to Overcome Ovarian Cancer (NCT NCT04927013)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2331 participants

Primary outcome timeframe

Up to 19 months

Results posted on

2024-10-03

Participant Flow

Participant enrollment began July 24, 2021 and all follow up was complete by February 21, 2023. Participants were identified from the Georgia Cancer Registry (GCR) which includes persons diagnosed with cancer in the state of Georgia, USA.

Participant milestones

Participant milestones
Measure	Message-based Outreach Intervention (MBI) 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. 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 code 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling. 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 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. Message-based Outreach Intervention for Close Relatives: Relatives will receive a unique website login code 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 Close relatives of cancer survivors who were randomized to receive the standard outreach. Close relatives will receive a unique login code to access a condensed version of the study website and free genetic counseling. 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.
Overall Study STARTED	969	969	152	241
Overall Study COMPLETED	130	184	19	1
Overall Study NOT COMPLETED	839	785	133	240

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Connecting Families to Overcome Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Message-based Outreach Intervention (MBI) for Survivors n=130 Participants 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 n=184 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.	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 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.	Total n=314 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	93 Participants n=7 Participants	—	—	166 Participants n=21 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants	91 Participants n=7 Participants	—	—	148 Participants n=21 Participants
Age, Continuous	62.5 years STANDARD_DEVIATION 13.0 • n=5 Participants	63.5 years STANDARD_DEVIATION 12.5 • n=7 Participants	—	—	63.1 years STANDARD_DEVIATION 12.7 • n=21 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	184 Participants n=7 Participants	—	—	314 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	—	—	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants n=5 Participants	179 Participants n=7 Participants	—	—	305 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	—	—	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	32 Participants n=7 Participants	—	—	60 Participants n=21 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	149 Participants n=7 Participants	—	—	250 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Region of Enrollment United States	130 Participants n=5 Participants	184 Participants n=7 Participants	—	—	314 Participants n=21 Participants
Age at diagnosis	52.7 years STANDARD_DEVIATION 12.6 • n=5 Participants	53.6 years STANDARD_DEVIATION 12.6 • n=7 Participants	—	—	53.3 years STANDARD_DEVIATION 12.6 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=969 Participants 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 n=969 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Survivors Using Website Access Code	147 Participants	202 Participants

PRIMARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes individuals who used their unique login code to access the study website.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=147 Participants 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 n=202 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Survivors Consenting to Participate in the Study	130 Participants	184 Participants

PRIMARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes individuals who gave consent to participate in the study.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=130 Participants 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 n=184 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Survivors Creating a Study Login	126 Participants	174 Participants

PRIMARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes close relatives of cancer survivors who were identified by the survivors to be contacted and offered the opportunity to participate in the study.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=152 Participants 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 n=241 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Relatives of Survivors Using the Website Access Code	20 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes close relatives who accessed the study website.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=20 Participants 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 n=1 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Relatives of Survivors Consenting to Participate in the Study	19 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 19 months

Population: This analysis population includes close relatives who gave consent to participate in the study.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=19 Participants 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 n=1 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Relatives of Survivors Creating a Login	19 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis population includes cancer survivors who accessed the website and selected a contact method for the close relatives that they provided contact information for. Survivors could identify more than one close relative and some did not identify any relatives.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=136 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Relative Contact Option Selected by Survivors Survivor Participant Selected "Self-Contact"	78 Participants	—
Relative Contact Option Selected by Survivors Survivor Participant Selected "Study Team Contact"	34 Participants	—
Relative Contact Option Selected by Survivors Survivor Participant Selected "Delay Contact"	24 Participants	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis includes participants who accessed the study website.

The request rate of cancer genetic services is assessed as the number of cancer survivors who requested telegenetic counseling on the website.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=147 Participants 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 n=202 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Survivors Requesting Telegenetic Counseling	26 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis includes participants who requested telegenetic counseling on the website.

Uptake of cancer genetic services is assessed as the number of survivors who completed telegenetic counseling.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=26 Participants 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 n=17 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Survivors Completing Telegenetic Counseling	15 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis population includes close relatives who gave consent to participate in the study.

The request rate of cancer genetic services is assessed as the number of close relatives who requested telegenetic counseling on the website.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=19 Participants 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 n=1 Participants Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Relatives Requesting Telegenetic Counseling	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis includes relatives who requested telegenetic counseling on the website.

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.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=9 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Relatives Completing Telegenetic Counseling	8 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes survivors in the MBI study arm who created a personal study login and used the website. Ten participants had no website activity after creating their login.

The duration of time (in minutes) that survivors in the Message-based Outreach Intervention (MBI) study arm spent on the website was examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=116 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Time Visiting Website by Survivors	14.81 minutes Standard Deviation 15.68	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes close relatives of survivors in the MBI study arm who gave consent to participate in the study.

Among those in the intervention arm, the duration of time (in minutes) that relatives of survivors spend on the website was examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=19 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Time Visiting Website by Relatives	6.78 minutes Standard Deviation 3.42	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes survivors in the MBI study arm who created a personal study login and used the website. Ten participants had no website activity after creating their login.

The number of return visits to the website by survivors in the MBI study arm was examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=116 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Return Visits to Website by Survivors	1.56 return visits Standard Deviation 1.25	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis population includes close relatives of survivors in the MBI study arm who gave consent to participate in the study.

Among those in the intervention arm, the number of return visits to the website by relatives of survivors was examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=19 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Return Visits to Website by Relatives	1.31 return visits Standard Deviation 0.58	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: The analysis population includes survivors in the MBI study arm who created a personal study login and used the website. Ten participants had no website activity after creating their login.

The number of website page viewed by survivors in the MBI study arm was examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=116 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Pages Viewed by Survivors	10.25 number of pages viewed Standard Deviation 7.99	—

SECONDARY outcome

Timeframe: Up to 19 months

Population: This analysis population includes close relatives of survivors in the MBI study arm who gave consent to participate in the study.

Among those in the intervention arm, the number of website pages viewed by relatives of survivors will be examined.

Outcome measures

Outcome measures
Measure	Message-based Outreach Intervention (MBI) for Survivors n=19 Participants 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 Cancer survivors randomized to receive the standard outreach consisting of a standard letter with a unique website login code, access to a condensed version of the study website, and free genetic counseling.
Number of Pages Viewed by Relatives	13.37 number of pages viewed Standard Deviation 3.83	—

Adverse Events

Message-based Outreach Intervention (MBI) for Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Outreach for Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Message-based Outreach Intervention for Close Relatives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Outreach for Close Relatives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yue Guan, PhD

Emory University

Phone: 404-712-1671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place