Clinical trial NCT02917798: Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
Official title: Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Prostate Cancer
Pancreas Cancer
Keywords: Genetic Testing
16-919
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-09-28
Enrollment: 1047
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian, prostate or pancreas cancer who are considered appropriate for multiplex genetic testing by their MSK DMT physician.

Brief summary: This study will evaluate patients' experiences with having gynecologic or prostate medical oncologists and surgeons offer them genetic testing, and having genetic counselors return the test results to patients over the telephone. This is different from the usual approach to genetic testing, where gynecologic or prostate medical oncologists and surgeons refer their patients to a genetic counselor in order to have these tests done, and the genetic counselors return the test results to the patient in person or over the telephone. The investigators will only be evaluating this alternative way of providing genetic testing to ovarian or prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* MSK patient age 18 years or older.
* Diagnosed with or presumed by physician to have prostate cancer, or pancreatic cancer and recommended to undergo, currently undergoing, or having undergone active surveillance. (Patients with invasive epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, or pancreas cancer are no longer eligible for inclusion as of Amendment 9. Patients with advanced prostate cancer who have not participated in active surveillance are no longer eligible for inclusion as of Amendment 10)
* Deemed to be clinically appropriate for multiplex genetic testing by their physician.
* Agreed to receive clinical multiplex genetic testing from their physician.
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.

Exclusion Criteria:

* Patients who do not or will not receive their ongoing cancer care at MSK.
* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
* For ovarian cancer patients only: patient insured by a payer that does not provide coverage for multiplex genetic testing as delivered in this protocol (e.g., Cigna, United Health Care, or Oxford, (because these payers require genetic counseling by a genetics professional prior to testing).

Primary outcomes:
measure: baseline to post-results change in distress levels
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Maria Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References: