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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02917798
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : October 4, 2023
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Ovarian Cancer Prostate Cancer Pancreas Cancer Behavioral: Assessments

Study Design
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Study Type : Observational
Estimated Enrollment : 1022 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
Actual Study Start Date : July 12, 2016
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Behavioral: Assessments


Outcome Measures
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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


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917798


Contacts
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Contact: Maria Carlo, MD 646-422-4438 carlom@mskcc.org
Contact: Mark Robson, MD 646-888-4058

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Maria Carlo, MD    646-422-4438      
Principal Investigator: Maria Carlo, MD         
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Maria Carlo, MD    646-422-4438      
Principal Investigator: Maria Carlo, MD         
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Maria Carlo, MD    646-422-4438      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maria Carlo, MD    646-422-4438      
Principal Investigator: Maria Carlo, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States
Contact: Maria Carlo, MD    646-422-4438      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
United States Department of Defense
Investigators
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Principal Investigator: Maria Carlo, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02917798    
Other Study ID Numbers: 16-919
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023
Keywords provided by Memorial Sloan Kettering Cancer Center:
Genetic Testing
16-919
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases