Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes

Prostate Cancer Clinical Trial

Official title:

Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917798
• Other study ID #: 16-919
• Status: Recruiting
• Start date: July 12, 2016
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Maria Carlo, MD
• Phone: 646-422-4438
• Email: carlom[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ovarian Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer

Intervention

Behavioral:
• Assessments

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	baseline to post-results change in distress levels	Change in distress levels (HADS-Anxiety) from Baseline to Assessments #2 and #3, measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance	2 years

External Links

•   Memorial Sloan Kettering Cancer Center