Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04746794 |
| Other study ID # |
STUDY00009476 |
| Secondary ID |
1U01CA232795-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2020 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study intervention involves having patients complete a familial cancer risk assessment
survey. Those who are found to be at high risk will be offered genetic testing for a panel of
hereditary cancers. A "previvor" plan will be created to assist patients and their providers
in completing the appropriate follow-up for those with a mutation identified.
Description:
Current practice guidelines from ACMG (American College of Medical Genetics and Genomics)
provide referral indications for cancer predisposition assessment. Identifying patients with
high genetic risk for breast, ovary, colon, or other cancers has important clinical
ramifications for an individual's healthcare, but genetic risk if often not identified
because of testing barriers at several levels. Barriers at the provider level include
inadequacies in risk recognition, patient referrals and availability of genetic professionals
to provide counseling in a traditional testing paradigm. Barriers at the level of the patient
include poor understanding of the availability and benefits of testing and inadequate access
to testing services. How to best implement appropriate genomic testing and follow-up care
into an operating healthcare system is not known. Issues of communication, clinical flow,
reportable actions, and transmission of information and support are of critical importance,
and must change and grow to accommodate the new information contained within genomic testing.
Studies to date of the implementation process have been conducted in high resourced
facilities, under optimal conditions, often not at the system level. Aims include:
1. Compare the efficacy and implementation of two strategies for identifying members of a
primary care clinic's population who have a family or personal history of cancer and
offering high-risk individuals to obtain genetic testing for cancer susceptibility
mutations in a randomized trial. The two methods are: 1) Point of Care (POC) approach: A
tablet-based screening for family/personal history of cancer will be offered to all
patients aged 25 and up coming in for a routine appointment at the clinic. 2) Direct
Patient Engagement (DPE): Letters will be sent to all individuals aged 25 and older in a
clinic's population, inviting them to visit a web site for screening for family
/personal history of cancer. In both strategies, those determined to be high-risk will
receive online education about genetic testing and an invitation to obtain such testing
through a web-based platform. Outcomes will be the fraction of the active clinic patient
population that completes screening and the fraction of the active clinic patient
population that undergoes testing.
Hypothesis 1: DPE screening will result in a higher proportion of active patients who
screen for familial cancer risk compared with POC screening.
Hypothesis 2: Of screened patients, POC patients will produce a higher proportion of
tested patients compared with DPE.
2. Identify changes, problems, and inefficiencies in clinical flow and interactions during
and after the implementation of genomic testing for cancer risk across primary care
clinics.
3. Evaluate the effects of two methods of implementation of genomic screening for cancer
risk on patient, provider, and health system leader reports of benefits and harms,
satisfaction, perceived quality of care, including across gender, racial/ethnic,
socioeconomic, and genetic literacy divides.
4. Evaluate the value (cost-effectiveness) and affordability (budget impact) of each
screening strategy.
