Evaluating An Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study Of Patient Outcomes

Study Overview

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

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.

N/A

Ovarian Cancer
Prostate Cancer
Pancreas Cancer

BEHAVIORAL: Assessments

16-919

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-06-07
First Submitted that Met QC Criteria 2016-09-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-06-10
First Posted (ACTUAL) 2016-09-28	Results First Posted N/A	Last Verified 2024-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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	BEHAVIORAL: Assessments

Participant Group/Arm

Intervention/Treatment

: 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

BEHAVIORAL: Assessments

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Maria Carlo, MD

Phone Number: 646-422-4438

Email: carlom@mskcc.org

Study Contact Backup

Name: Mark Robson, MD

Phone Number: 646-888-4058

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
FEMALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

United States Department of Defense

Investigators

PRINCIPAL_INVESTIGATOR: Maria Carlo, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record