Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research.
Lawrence A Palinkas, Sarah M Horwitz, Carla A Green...
https://pubmed.ncbi.nlm.nih.gov/24193818Actively Recruiting
Led by Weill Medical College of Cornell University · Updated on 2025-12-26
550
Participants Needed
5
Research Sites
78 weeks
Total Duration
W
Weill Medical College of Cornell University
Lead Sponsor
M
Myriad Genetics, Inc.
Collaborating Sponsor
This research aims to evaluate the interest and acceptability of adding hereditary cancer screening (HCS) alongside standard obstetric carrier screening (OCS) among women receiving routine prenatal or preconception/fertility care. The study addresses the opportunity pregnancy offers for early cancer prevention, particularly in underserved populations, by assessing whether universal screening during this time is feasible and potentially cost-effective. It focuses on BRCA1/2 genetic testing, which is not typically included in standard OCS despite its importance for cancer risk assessment. Participants will be offered combined HCS and OCS either during obstetrical/prenatal visits or at reproductive endocrinology and infertility clinics. If they choose to proceed with OCS, a genetics clinician will provide counseling about HCS, including its risks, benefits, and possible outcomes. This trial evaluates patient decisions to accept HCS in addition to OCS and follows established counseling and consent procedures. During the study, researchers will track how many participants complete both HCS and OCS tests within about two years. They will also measure participant experiences through various questionnaires and interviews, including distress levels and satisfaction with genetic counseling and decision-making. High-risk participants will be monitored for use of cancer prevention strategies up to 18 months after screening. Provider experiences will also be collected. Overall, the study lasts through recruitment and follow-up periods, aiming to understand acceptability and outcomes of combined genetic screening.
CONDITIONS
Trial of Combined Obstetric Carrier Screening and Hereditary Cancer Screening
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or by telephone)
Duration - Up to 2 years or until recruitment ends
Participants receive combined hereditary cancer screening (HCS) and obstetric carrier screening (OCS) during prenatal or preconception care. A genetics clinician provides counseling on the risks, benefits, and implications of HCS.
1 genetics counseling session (in-person or by telephone) plus OCS during standard prenatal or preconception care visits
Duration - Up to 18 months after screening completion
Participants are followed to assess utilization of cancer risk mitigation strategies and to gather feedback on their experience with combined HCS and OCS.
Questionnaires and interviews conducted following genetic counseling and screening
Total: 5 locations
1
Reproductive Medicine
Brooklyn, New York, United States, 11201
Actively Recruiting
2
NewYork-Presbyterian Weill Cornell Medicine
Brooklyn, New York, United States, 11215
Not Yet Recruiting
3
Reproductive Medicine
New York, New York, United States, 10021
Actively Recruiting
4
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
5
NewYork-Presbyterian Weill Cornell Medicine Queens
Queens, New York, United States, 11355
Actively Recruiting
S
Steve Lopez, BA
R
Ravi Sharaf, MD, MS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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