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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

Tracking Information
First Submitted Date September 22, 2016
First Posted Date September 28, 2016
Last Update Posted Date October 4, 2023
Actual Study Start Date July 12, 2016
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2016)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
Official Title Evaluating an Alternative Clinical Genetics Cancer Care Delivery Model: A Pilot Study of Patient Outcomes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
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.
Condition
  • Ovarian Cancer
  • Prostate Cancer
  • Pancreas Cancer
Intervention Behavioral: Assessments
Study Groups/Cohorts 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.
Intervention: Behavioral: Assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2020)		 1022
Original Estimated Enrollment
 (submitted: September 26, 2016)		 200
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maria Carlo, MD 646-422-4438 carlom@mskcc.org
Contact: Mark Robson, MD 646-888-4058
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02917798
Other Study ID Numbers 16-919
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor Memorial Sloan Kettering Cancer Center
Original Study Sponsor Same as current
Collaborators United States Department of Defense
Investigators
Principal Investigator: Maria Carlo, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2023