Clinical trial NCT05162846: Methods for Increasing Genetic Testing Uptake in Michigan
Official title: Methods for Increasing Genetic Testing Uptake in Michigan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Ovarian Cancer
Prostate Cancer
Pancreatic Cancer
Endometrial Cancer
History of Cancer
Keywords: Genetic testing
Genetic susceptibility to malignant neoplasm
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-17
Enrollment: 831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.

Detailed description: This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC).

As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.

Eligibility criteria: Inclusion Criteria:

* Able to speak and read English
* Access to the internet
* Completed the Family Health History Tool (FHHT)
* Meeting clinical criteria for genetic evaluation due to any of the below:

  1. Personal history of Breast cancer either:

     * i. Diagnosed under 50
     * ii. Personal or family history of triple negative breast cancer
     * iii. Ashkenazi Jewish ancestry
     * iv. Male proband
     * v. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
  2. Personal history of prostate cancer either:

     * i. Diagnosed under 50
     * ii. Ashkenazi Jewish ancestry
     * iii. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
  3. Personal history of any cancer or no personal history of cancer with either:

     * i. PREMM score ≥ 2.5%
     * ii. 1st degree relative with pancreatic, or male breast cancer
     * iii. 1st or 2nd degree relative with ovarian cancer
     * iv. 1st degree relative with any of these cancers diagnosed under 50: colon, endometrial, or breast
     * v. Ashkenazi Jewish ancestry and 1st or 2nd degree relative with breast cancer
  4. Personal history of endometrial cancer diagnosed under 50
  5. Personal history of colorectal cancer diagnosed under 50
  6. Personal history of renal cancer diagnosed under 46
  7. Personal history of sarcoma diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56
  8. Personal history of brain cancer diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56
  9. Personal history of any two of the following cancers with at least one of them diagnosed under 46: breast, sarcoma, or brain
  10. Personal history of ovarian cancer
  11. Personal history of pancreatic cancer
  12. Personal history of adrenal cortical carcinoma

Exclusion Criteria:

* Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider

Primary outcomes:
measure: Percentage of participants who complete clinical genetic testing at six months after randomization
timeFrame: 6 months after enrollment/randomization
Secondary outcomes:
measure: Barriers to genetic testing, for participants who completed genetic testing
timeFrame: 6 months and 12 months after enrollment/randomization
measure: Barriers to genetic testing, for participants who did not yet complete genetic testing
timeFrame: 6 months and 12 months after enrollment/randomization
measure: Motivators of genetic testing, for participants who completed genetic testing
timeFrame: 6 months and 12 months after enrollment/randomization
measure: Motivators of genetic testing, for participants who did not yet complete genetic testing
timeFrame: 6 months and 12 months after enrollment/randomization
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Elena Stoffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: