This trial studies clinical genetics cancer care delivery model in evaluating psychological and behavioral implications in patients with ovarian, peritoneal, fallopian tube, prostate, or pancreatic cancer. The clinical genetics cancer care delivery model may allow the Memorial Sloan Kettering Cancer Center Clinical Genetics Service to efficiently and effectively meet patient preferences for timely genetic risk information.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02917798.
PRIMARY OBJECTIVES:
I. To evaluate the acceptability (operationalized as emotional distress, satisfaction with genetic testing decision, and satisfaction with genetic counseling) of an alternative clinical genetics cancer care delivery model involving standardized pre-test education delivered by a non-genetics healthcare provider plus post-test telephone counseling by a certified genetic counselor.
Ia. To identify sociodemographic and dispositional characteristics (operationalized as sociodemographic variables and ambiguity aversion) of patients who report poorer acceptability (operationalized as emotional distress, satisfaction with genetic testing decision, and satisfaction with genetic counseling) of the alternative clinical genetics cancer care delivery model.
II. To describe additional psychological (operationalized as knowledge and concerns about genetic testing; for patients with early-stage prostate cancer, also operationalized as prostate-specific anxiety and perceived risk of disease progression) and behavioral (operationalized as coping with genetic testing and communication about genetic testing; for patients with early-stage prostate cancer, also operationalized as behavioral intentions to pursue treatment) outcomes of the alternative clinical genetics cancer care delivery model for patients receiving different genetic test results (e.g., pathogenic variant[s], no pathogenic variant[s], variant(s) of uncertain significance).
III. To compare clinical characteristics and outcomes in carriers of pathogenic variants versus (vs) non-carriers.
OUTLINE: This is an observational study.
Patients undergo collection of blood or saliva sample for multiplex genetic testing and receive telephone genetic counseling over 30 minutes. Patients also complete assessment questionnaires over 15 minutes.
After completion of study, patients are followed up at 1 week, 6 months, and 12 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMaria Isabel Carlo
