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

NCT02917798 | Active Not Recruiting

• 1 other identifier: 16-919
• Study Type: observational
• Target: 1,047
• Locations: 1 country
• Sites: 5

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.

Conditions

Ovarian Cancer; Prostate Cancer; Pancreas Cancer

Keywords

Genetic Testing; 16-919

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Genetic Testing in Ovarian ,Prostate or Pancreas Cancer

This study is a prospective single-arm study to examine how an alternative clinical genetics cancer care delivery model affects ovarian, prostate or pancreas cancer patients' cognitions, emotions, and behaviors. Participants will be contacted 1 week (+/- 1 week) (Assessment #2; and 3 months (+/- 2 weeks) (Assessment #3;) following the telephone post-test counseling session to complete the follow-up assessments. These assessments will measure psychological and behavioral study constructs.

Behavioral: Assessments

Interventions

Assessments BEHAVIORAL

Genetic Testing in Ovarian ,Prostate or Pancreas Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• MSK patient age 18 years or older.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (5)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Ovarian Neoplasms; Prostatic Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Maria Carlo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 28, 2016
• Study Start: July 12, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (5)