Message-Based Communication Outreach Intervention in Engaging Ovarian Cancer Survivors and Relatives to Consider Genetic Screening Services
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
25 Years and older, Female
RSPH4984-20 (primary)
NCI-2020-02281
STUDY00000224
Summary
This trial studies how well a message-based communication outreach intervention works in engaging ovarian cancer survivors and their relatives to consider genetic screening services. This study may help the researchers identify best methods to engage cancer survivors and at-risk relatives to provide education regarding screening tools such as genetic testing. By providing outreach interventions, patients may develop a broader knowledge base, competence and confidence about genetic testing, which may improve future patient outcomes.
Objectives
PRIMARY OBJECTIVES:
I. To enlist community partners as citizen scientists to: identify and recruit Georgia residents with a personal/family history of ovarian cancer, generate content, and collaborate on a scalable message-based outreach intervention to reach ovarian cancer survivors and close relatives (i.e., first- and second-degree relatives) to consider genetic service options.
II. To compare a message-based outreach intervention to standard outreach for effects on: survivor reach, relative reach, and uptake of appropriate cancer genetic services (i.e., genetic counseling and testing for survivors, online genetic risk assessment for relatives) among survivors of ovarian cancer identified via a state cancer registry.
III. To conduct a process evaluation consistent with the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework alongside the randomized controlled trial (RCT) to measure: reactions, dose delivered/received, fidelity, acceptability, barriers/facilitators, and alignment with ethical principles.
OUTLINE:
PHASE I: Patients and family member participate in working groups to develop targeted letters, choice options for relative outreach, content for an interactive website, and short cueing messages that engage ovarian cancer survivors and their at-risk relatives in considering genetic risk assessment.
PHASE II: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive a standard letter and login information for condensed version of website that includes information on genetic risk and genetic counseling, patient navigators in their locale, and the importance of conveying information to close relatives. Patients also receive 2 extra letters and login information for 2 close relative.
GROUP II: Patients receive a letter with targeted messages and unique login information for expanded website. Patients also receive 2 text messages at 3-week intervals over a 6-week time period. Patients choice relatives may also receive a letter with targeted messages, and unique login information for an expanded website.
THE THINK ALOUD SUBSTUDY: Patients receive access to YourFamilyConnects website to review content and attend a one-on-one interview over 90 minutes on study.
Eligibility
- AIM 1:
- English-speaking
- Have a personal and/or family history of ovarian cancer
- 25 years or older
- Have access to the internet and be available to attend in-person or online focus group discussions
- AIM 2 (survivors):
- Diagnosed with ovarian, fallopian tube, or peritoneal cancers
- Lived in Georgia at the time of diagnosis, not deceased, and have a mailing address per the Georgia Cancer Registry (GCR)'s records
- AIM 2 (relatives of survivors):
- Able to read English
- Be 25 years or older
- Have access to the internet
- Be a first- or second-degree relative of the survivor
- Not be incarcerated or institutionalized
- AIM 2 & 3 (post-intervention online survey):
- Survivors and relatives in both arms who login to the study website
- AIM 3 (mail survey to survivors who did not login to the study website):
- Survivors who do not visit the website approximately 6 weeks after the third and final mailing
- AIM 3 (online discussion forum):
- Survivors and relatives randomized to the message based intervention (MBI) arm who login to the study website
- THE THINK ALOUD SUBSTUDY: Ovarian cancer survivors who did not log on to the YFC website during the study recruitment period
- THE THINK ALOUD SUBSTUDY: Speak English
- THE THINK ALOUD SUBSTUDY: Can use the internet
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