Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling

May 22, 2026 updated by: Memorial Sloan Kettering Cancer Center
The objective of this protocol is to characterize cancer patients' responses to learning their secondary findings arising from tumor genomic profiling, and the process and outcomes of their decisions to communicate these results to their families.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

For Phase 1 of this study, the investigators will conduct a prospective, observational study with cancer patients undergoing tumor genomic profiling (n = 300) and their family members (anticipated n ≈ 150). Data collection will occur through an embedded mixed methods design, in which both quantitative (i.e., survey) and qualitative (i.e., semi-structured interview) data are collected at the same timepoint in order to obtain a more complete understanding of specific processes and outcomes.

They will be recruited from those who already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.

For Phase 2 of this study, participants (n=500) who have received pathogenic secondary findings through protocol #12-245 will be recruited.

For Phase 3, efforts will be expanded from the adult populations explored in the preceding phases to the experiences of patients affected by pediatric cancers and their families. Cross-sectional mixed methods data from AYA survivors of pediatric cancers (n=50) and adult caregivers of survivors of pediatric cancer (n=50) will be collected.

Study Type

Observational

Enrollment (Actual)

495

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

Yes

Sampling Method

Non-Probability Sample

Study Population

300 participants for the proposed study from those already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.

Description

Inclusion Criteria:

Patients (Phase I):

  • 18 years of age or older
  • Has consented to MSK IRB protocol #12-245, Consent A and Part C
  • Has not received secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or patient report
  • Diagnosed with a solid tumor as per EMR and/or clinician judgment
  • 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.

Family members (Phase I):

  • 18 years of age or older as per self report
  • Nominated by the patient participant as a family member with whom the secondary findings have been shared (spouses/partners are eligible as "family members" for the purposes of this study)
  • 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 (Phase 2):

  • 18 years of age of older
  • Has consented to MSK IRB protocol #12-245, Consent Part A and C
  • 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. Therefor, participants must be able to communicate in English to complete the surveys.

AYA Survivors of Pediatric Cancers (Phase 3):

  • Age 15 to 30 years old
  • Are at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
  • Has consented or provided assent to MSK IRB protocol #12-245, Consent Part A and C
  • Has received pathogenic secondary findings as a result of MSK IRB protocol #12- 245, Consent Part C as per EMR and/or CGS care provider report
  • Participated in a CGS consultation following receipt of secondary findings
  • 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.

Adult Caregivers of Survivors of Pediatric Cancers (Phase 3):

  • 18 years of age or older

  • Are the caregiver of a child who was treated for pediatric cancer (i.e., any cancer diagnosed before age 18). Caregiver status is based on either: 1) nomination as such by a young adult survivor (i.e., age 18+), 2) having consented on behalf of a minor child (i.e., age <18) to MSK IRB protocol

    #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child, or 3) nomination by the adult who consented on behalf of a minor child (i.e., age <18) to MSK IRB protocol #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child

  • That child is currently alive and at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
  • Has consented on behalf of that child, or that child consented, to MSK IRB protocol #12-245, Consent Part A and C
  • That child received pathogenic secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or CGS healthcare provider report
  • Participated in a CGS consultation following receipt of secondary findings
  • 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:

  • Received genetic testing in the past that resulted in a pathogenic finding or a variant of unknown significance as reported in the EMR.
  • Major psychiatric illness or cognitive impairment that in the judgment of the investigator 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The investigators will assess patients' emotional responses to receiving their secondary findings
Time Frame: 1 year
Through quantitative (i.e., survey) assessments, the investigators will assess patients' emotional (both positive and negative) responses to receiving their secondary findings, and their perceptions regarding the utility of this information and communicating it to family.
1 year

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jada Hamiliton, PhD, MPH, 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

February 25, 2016

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

February 25, 2027

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimated)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-080

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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