- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917798
Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
October 3, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1022
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: Mark Robson, MD
- Phone Number: 646-888-4058
Study Contact Backup
- Name: Maria Carlo, MD
- Phone Number: 646-422-4438
- Email: carlom@mskcc.org
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States
- Recruiting
- Memorial Sloan Kettering Basking Ridge
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Contact:
- Maria Carlo, MD
- Phone Number: 646-422-4438
-
Principal Investigator:
- Maria Carlo, MD
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New York
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Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
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Contact:
- Maria Carlo, MD
- Phone Number: 646-422-4438
-
Principal Investigator:
- Maria Carlo, MD
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Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
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Contact:
- Maria Carlo, MD
- Phone Number: 646-422-4438
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Maria Carlo, MD
- Phone Number: 646-422-4438
-
Principal Investigator:
- Maria Carlo, MD
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Rockville Centre, New York, United States
- Recruiting
- Memorial Sloan Kettering Rockville Centre
-
Contact:
- Maria Carlo, MD
- Phone Number: 646-422-4438
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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 (+/- 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maria Carlo, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start (Actual)
July 12, 2016
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 26, 2016
First Posted (Estimated)
September 28, 2016
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-919
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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