History of Changes for Study: NCT02917798

Streamlining the Delivery of Genetic Testing in the Ovarian Cancer Context: A Pilot Study of Patient Outcomes

Latest version (submitted October 3, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	September 26, 2016	None (earliest Version on record)
2	March 8, 2017	Study Status, Groups and Interventions, Eligibility and Study Description
3	July 20, 2017	Study Status, Groups and Interventions, Eligibility, Study Identification, Contacts/Locations and Conditions
4	September 26, 2017	Eligibility and Study Status
5	October 30, 2017	Study Status
6	January 2, 2018	Study Status
7	June 22, 2018	Study Status and Contacts/Locations
8	September 10, 2018	Study Status
9	September 10, 2019	Study Status and Study Design
10	October 3, 2019	Study Status
11	April 23, 2020	Study Status, Eligibility and Study Design
12	September 29, 2020	Study Status
13	October 1, 2020	Study Status and Sponsor/Collaborators
14	November 24, 2020	Study Status
15	February 23, 2021	Contacts/Locations and Study Status
16	June 8, 2021	Study Status
17	February 22, 2022	Study Status
18	October 3, 2022	Study Status and Contacts/Locations
19	October 3, 2023	Study Status

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Study NCT02917798
Submitted Date: September 26, 2016 (v1)

Study Identification


Unique Protocol ID:	16-919
Brief Title:	Streamlining the Delivery of Genetic Testing in the Ovarian Cancer Context: A Pilot Study of Patient Outcomes
Official Title:	Streamlining the Delivery of Genetic Testing in the Ovarian Cancer Context: A Pilot Study of Patient Outcomes
Secondary IDs:

Study Status


Record Verification:	September 2016
Overall Status:	Recruiting
Study Start:	July 2016
Primary Completion:	September 2017 [Anticipated]
Study Completion:

First Submitted:	September 22, 2016
First Submitted that Met QC Criteria:	September 26, 2016
First Posted:	September 28, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	September 26, 2016
Last Update Posted:	September 28, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Memorial Sloan Kettering Cancer Center
Responsible Party:	Sponsor
Collaborators:

Study Description

Brief Summary:

This study will evaluate patients' experiences with having gynecologic 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 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 cancer patients.

Detailed Description:

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	Blood
Enrollment:	200 [Anticipated]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts

Interventions

Genetic Testing in Ovarian Cancer

This study is a prospective single-arm study to examine how an alternative clinical genetics cancer care delivery model affects ovarian 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

Outcome Measures


Primary Outcome Measures:
1.	baseline to post-results change in distress levels [ Time Frame: 2 years ] 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

Eligibility


Study Population:	Patients with ovarian cancer who are considered appropriate for multiplex genetic testing by their MSK Gyn DMT physician.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: MSK patient age 18 years or older. Diagnosed with invasive epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer. Deemed to be clinically appropriate for multiplex genetic testing by their MSK Gyn DMT physician. Agreed to receive clinical multiplex genetic testing from their MSK Gyn DMT 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. 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).

Contacts/Locations


Central Contact Person:	Mark Robson, MD Telephone: 646-888-4058
Central Contact Backup:	Jada Hamilton, PhD, MPH Telephone: 646-888-0049
Study Officials:	Mark Robson, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Locations:	United States, New Jersey
	Memoral Sloan Kettering Cancer Center [Recruiting] Basking Ridge, New Jersey, United States Contact:Contact: Mark Robson, MD 646-888-4058 Contact:Principal Investigator: Mark Robson, MD
	United States, New York
	Memorial Sloan-Kettering Cancer Center @ Suffolk [Recruiting] Commack, New York, United States, 11725 Contact:Contact: Mark Robson, MD 646-888-4058 Contact:Principal Investigator: Mark Robson, MD
	Memorial Sloan Kettering Cancer Center [Recruiting] New York, New York, United States, 10065 Contact:Contact: Mark Robson, MD 646-888-4058 Contact:Contact: Jada Hamilton, PhD, MPH 646-888-0049 Contact:Principal Investigator: Mark Robson, MD
	Memorial Sloan Kettering at Mercy Medical Center [Recruiting] Rockville Centre, New York, United States Contact:Contact: Mark Robson, MD 646-888-4058
	Memorial Sloan Kettering Westchester [Recruiting] West Harrison, New York, United States, 10604 Contact:Contact: Mark Robson, MD 646-888-4058

References


Citations:
Links:	URL: https://www.mskcc.org/ Description: Memorial Sloan Kettering Cancer Center
Available IPD/Information:

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