Ovarian CancerNCT04927013
Connecting Families to Overcome Ovarian Cancer
A study testing Message-based Outreach Intervention for Survivors, Standard Outreach for Survivors and Message-based Outreach Intervention for Close Relatives in people with Ovarian Cancer, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Message-based Outreach Intervention for Survivors, Standard Outreach for Survivors and Message-based Outreach Intervention for Close Relatives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,331 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2021to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 25 years or older
Show all 10Show fewer
- able to access the internet
- a 1st or 2nd degree relative of the survivor
- able to read English
- non-incarcerated or institutionalized
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Message-based Outreach Intervention for Survivors, Standard Outreach for Survivors, Message-based Outreach Intervention for Close Relatives, Standard Outreach for Close Relatives
- Keywords
- Genetic counseling, Risk assessment, Family communication, Genetic risk communication
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message-based Outreach Intervention for SurvivorsBehavioural
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 SurvivorsBehavioural
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 RelativesBehavioural
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 RelativesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Experimental | 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. Receives: Behavioral: Message-based Outreach Intervention for Survivors |
| Standard Outreach for Survivors | Active comparator | 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. Receives: Behavioral: Standard Outreach for Survivors |
| Message-based Outreach Intervention for Close Relatives | Experimental | 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. Receives: Behavioral: Message-based Outreach Intervention for Close Relatives |
| Standard Outreach for Close Relatives | Active comparator | 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. Receives: Behavioral: Standard Outreach for Close Relatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
Secondary outcomes (11)
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
Number of Survivors Completing Telegenetic Counseling
Uptake of cancer genetic services is assessed as the number of survivors who completed telegenetic counseling.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
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.
Measured: Up to 19 months
Number of Pages Viewed by Survivors
The number of website page viewed by survivors in the MBI study arm was examined.
Measured: Up to 19 months
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.
Measured: Up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start24 Jul 2021
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yue Guan, Emory University
- Investigators
- Colleen McBride, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927013
- Sponsor's protocol ID
- STUDY00000224
- Other IDs
- 1U01CA240581
- Status last verified
- Sep 2024
- First submitted
- 14 Jun 2021
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available for sharing, after de-identification.
Publications
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.
PubMed 38912902Shepperd JA, McBride CM, An W, Zhao J, Pentz RD, Escoffery C, Ward K, Guan Y. Trust and Privacy Concerns Among Cancer Survivors Who Did Not Visit a Research Website Offering Free Genetic Counseling Services for Families: Survey Study. J Med Internet Res. 2025 May 6;27:e64228. doi: 10.2196/64228.
PubMed 40327861
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04927013
- Acronym / sponsor ID
- STUDY00000224
- Conditions
- Ovarian Cancer
- Keywords
- Genetic counseling, Risk assessment, Family communication, Genetic risk communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,331 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Message-based Outreach Intervention (MBI) for Survivors | Experimental | Behavioral: Message-based Outreach Intervention for SurvivorsCancer 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 | Active comparator | Behavioral: Standard Outreach for SurvivorsCancer 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. |
| Message-based Outreach Intervention for Close Relatives | Experimental | Behavioral: Message-based Outreach Intervention for Close RelativesClose 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 | Active comparator | Behavioral: Standard Outreach for Close RelativesClose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Message-based Outreach Intervention for SurvivorsThe 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. | Behavioural | Message-based Outreach Intervention (MBI) for Survivors |
| Standard Outreach for SurvivorsThe 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. | Behavioural | Standard Outreach for Survivors |
| Message-based Outreach Intervention for Close RelativesRelatives 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. | Behavioural | Message-based Outreach Intervention for Close Relatives |
| Standard Outreach for Close RelativesThe 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. | Behavioural | Standard Outreach for Close Relatives |
Primary outcome
Number of Survivors Using Website Access Code
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Relative Contact Option Selected by Survivors
Time frame: Up to 19 months
Number of Survivors Requesting Telegenetic Counseling
Time frame: Up to 19 months
Number of Survivors Completing Telegenetic Counseling
Time frame: Up to 19 months
Number of Relatives Requesting Telegenetic Counseling
Time frame: Up to 19 months
Number of Relatives Completing Telegenetic Counseling
Time frame: Up to 19 months
Time Visiting Website by Survivors
Time frame: Up to 19 months
Time Visiting Website by Relatives
Time frame: Up to 19 months
Number of Return Visits to Website by Survivors
Time frame: Up to 19 months
Number of Return Visits to Website by Relatives
Time frame: Up to 19 months
Number of Pages Viewed by Survivors
Time frame: Up to 19 months
Number of Pages Viewed by Relatives
Time frame: Up to 19 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38912902Guan 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.
- Derived from this study: PubMed 40327861Shepperd JA, McBride CM, An W, Zhao J, Pentz RD, Escoffery C, Ward K, Guan Y. Trust and Privacy Concerns Among Cancer Survivors Who Did Not Visit a Research Website Offering Free Genetic Counseling Services for Families: Survey Study. J Med Internet Res. 2025 May 6;27:e64228. doi: 10.2196/64228.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available for sharing, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen McBride, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Message-based Outreach Intervention for Survivors, Standard Outreach for Survivors and Message-based Outreach Intervention for Close Relatives in people with Ovarian Cancer, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Survivors Using Website Access Code (time frame: Up to 19 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.