Ovarian Cancer
Conditions
Keywords
Genetic counseling, Risk assessment, Family communication, Genetic risk communication
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.
Interventions
BEHAVIORALMessage-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.
BEHAVIORALStandard 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.
BEHAVIORALMessage-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.
BEHAVIORALStandard 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.
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| 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. | 184 |
| 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. | 0 |
| 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. | 0 |
| Total | 314 |
Baseline characteristics
| Characteristic | Message-based Outreach Intervention (MBI) for Survivors | Standard Outreach for Survivors | Total |
|---|---|---|---|
| Age at diagnosis | 52.7 years STANDARD_DEVIATION 12.6 | 53.6 years STANDARD_DEVIATION 12.6 | 53.3 years STANDARD_DEVIATION 12.6 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 91 Participants | 148 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 93 Participants | 166 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 13 | 63.5 years STANDARD_DEVIATION 12.5 | 63.1 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 179 Participants | 305 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 32 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 149 Participants | 250 Participants |
| Region of Enrollment United States | 130 Participants | 184 Participants | 314 Participants |
| Sex: Female, Male Female | 130 Participants | 184 Participants | 314 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 969 | 0 / 969 | 0 / 152 | 0 / 241 |
| other Total, other adverse events | 0 / 969 | 0 / 969 | 0 / 152 | 0 / 241 |
| serious Total, serious adverse events | 0 / 969 | 0 / 969 | 0 / 152 | 0 / 241 |
Outcome results
Primary
Number of Relatives of Survivors Consenting to Participate in the Study
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.
Time frame: Up to 19 months
Population: The analysis population includes close relatives who accessed the study website.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Relatives of Survivors Consenting to Participate in the Study | 19 Participants |
| Standard Outreach for Survivors | Number of Relatives of Survivors Consenting to Participate in the Study | 1 Participants |
Primary
Number of Relatives of Survivors Creating a Login
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.
Time frame: Up to 19 months
Population: This analysis population includes close relatives who gave consent to participate in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Relatives of Survivors Creating a Login | 19 Participants |
| Standard Outreach for Survivors | Number of Relatives of Survivors Creating a Login | 0 Participants |
Primary
Number of Relatives of Survivors Using the Website Access Code
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Relatives of Survivors Using the Website Access Code | 20 Participants |
| Standard Outreach for Survivors | Number of Relatives of Survivors Using the Website Access Code | 1 Participants |
Primary
Number of Survivors Consenting to Participate in the Study
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.
Time frame: Up to 19 months
Population: The analysis population includes individuals who used their unique login code to access the study website.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Survivors Consenting to Participate in the Study | 130 Participants |
| Standard Outreach for Survivors | Number of Survivors Consenting to Participate in the Study | 184 Participants |
Primary
Number of Survivors Creating a Study Login
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.
Time frame: Up to 19 months
Population: The analysis population includes individuals who gave consent to participate in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Survivors Creating a Study Login | 126 Participants |
| Standard Outreach for Survivors | Number of Survivors Creating a Study Login | 174 Participants |
Primary
Number of Survivors Using Website Access Code
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.
Time frame: Up to 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Survivors Using Website Access Code | 147 Participants |
| Standard Outreach for Survivors | Number of Survivors Using Website Access Code | 202 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Pages Viewed by Relatives | 13.37 number of pages viewed | Standard Deviation 3.83 |
Secondary
Number of Pages Viewed by Survivors
The number of website page viewed by survivors in the MBI study arm was examined.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Pages Viewed by Survivors | 10.25 number of pages viewed | Standard Deviation 7.99 |
Secondary
Number of Relatives Completing Telegenetic Counseling
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 frame: Up to 19 months
Population: This analysis includes relatives who requested telegenetic counseling on the website.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Relatives Completing Telegenetic Counseling | 8 Participants |
| Standard Outreach for Survivors | Number of Relatives Completing Telegenetic Counseling | 0 Participants |
Secondary
Number of Relatives Requesting Telegenetic Counseling
The request rate of cancer genetic services is assessed as the number of close relatives who requested telegenetic counseling on the website.
Time frame: Up to 19 months
Population: This analysis population includes close relatives who gave consent to participate in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Relatives Requesting Telegenetic Counseling | 9 Participants |
| Standard Outreach for Survivors | Number of Relatives Requesting Telegenetic Counseling | 0 Participants |
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 was examined.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Return Visits to Website by Relatives | 1.31 return visits | Standard Deviation 0.58 |
Secondary
Number of Return Visits to Website by Survivors
The number of return visits to the website by survivors in the MBI study arm was examined.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Return Visits to Website by Survivors | 1.56 return visits | Standard Deviation 1.25 |
Secondary
Number of Survivors Completing Telegenetic Counseling
Uptake of cancer genetic services is assessed as the number of survivors who completed telegenetic counseling.
Time frame: Up to 19 months
Population: This analysis includes participants who requested telegenetic counseling on the website.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Survivors Completing Telegenetic Counseling | 15 Participants |
| Standard Outreach for Survivors | Number of Survivors Completing Telegenetic Counseling | 9 Participants |
Secondary
Number of Survivors Requesting Telegenetic Counseling
The request rate of cancer genetic services is assessed as the number of cancer survivors who requested telegenetic counseling on the website.
Time frame: Up to 19 months
Population: This analysis includes participants who accessed the study website.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Number of Survivors Requesting Telegenetic Counseling | 26 Participants |
| Standard Outreach for Survivors | Number of Survivors Requesting Telegenetic Counseling | 17 Participants |
Secondary
Relative Contact Option Selected by Survivors
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Relative Contact Option Selected by Survivors | Survivor Participant Selected Self-Contact | 78 Participants |
| Message-based Outreach Intervention (MBI) for Survivors | Relative Contact Option Selected by Survivors | Survivor Participant Selected Study Team Contact | 34 Participants |
| Message-based Outreach Intervention (MBI) for Survivors | Relative Contact Option Selected by Survivors | Survivor Participant Selected Delay Contact | 24 Participants |
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 was examined.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Time Visiting Website by Relatives | 6.78 minutes | Standard Deviation 3.42 |
Secondary
Time Visiting Website by Survivors
The duration of time (in minutes) that survivors in the Message-based Outreach Intervention (MBI) study arm spent on the website was examined.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Time Visiting Website by Survivors | 14.81 minutes | Standard Deviation 15.68 |