Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma
Conditions
Keywords
Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma
Brief summary
The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.
Detailed description
This study consists of two parts: * Qualitative assessment: * This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants. * The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial. * Randomized control trial: * A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants
Interventions
BEHAVIORALVideo Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
BEHAVIORALGenetic Counseling
Standard genetic counseling
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma * Ability to understand spoken or written English or Spanish in a healthcare context * Ability to understand and the willingness to sign a written informed consent document * Black or Latinx (qualitative assessment study only)
Exclusion criteria
* Prior cancer genetic testing * Prior germline genetic testing * Active hematologic malignancy (e.g. chronic lymphocytic leukemia) * Currently pregnant * Currently incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Video Education Acceptability (Qualitative Interview Study) | 3 Weeks | Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy. |
Countries
United States
Contacts
CONTACTHuma Q. Rana, MD. MPH
PRINCIPAL_INVESTIGATORHuma Q. Rana, MD., MPH
Dana-Farber Cancer Institute
Outcome results
None listed