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Message-Based Communication Outreach Intervention in Engaging Ovarian Cancer Survivors and Relatives to Consider Genetic Screening Services

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Eligibility
25 Years and older, Female
Study Type
Screening
NCT ID
NCT04927013
Protocol IDs
RSPH4984-20 (primary)
NCI-2020-02281
STUDY00000224
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Eligibility

  1. AIM 1:
  2. English-speaking
  3. Have a personal and/or family history of ovarian cancer
  4. Have access to the internet and be available to attend in-person or online focus group discussions
  5. AIM 2 (survivors):
  6. Diagnosed with ovarian, fallopian tube, or peritoneal cancers
  7. Lived in Georgia at the time of diagnosis, not deceased, and have a mailing address per the Georgia Cancer Registry (GCR)'s records
  8. AIM 2 (relatives of survivors):
  9. Able to read English
  10. Have access to the internet
  11. Be a first- or second-degree relative of the survivor
  12. Not be incarcerated or institutionalized
  13. AIM 2 & 3 (post-intervention online survey):
  14. Survivors and relatives in both arms who login to the study website
  15. AIM 3 (mail survey to survivors who did not login to the study website):
  16. Survivors who do not visit the website approximately 6 weeks after the third and final mailing
  17. AIM 3 (online discussion forum):
  18. Survivors and relatives randomized to the message based intervention (MBI) arm who login to the study website
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