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

NCT02713334 | Active Not Recruiting

• 1 other identifier: 16-080
• Study Type: observational
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tumor Genomic Profiling

Keywords

Decision Making; Communication; 16-080

Outcome Measures

Primary Outcomes (1)

• The investigators will assess patients' emotional responses to receiving their secondary findings

  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

Interventions

survey BEHAVIORAL

semi-structured interview BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients (Phase I):
• 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):
• 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):
• 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):

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Communication

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jada Hamiliton, PhD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: February 25, 2016
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)