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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:February 25, 2016
End Date:February 25, 2020
Contact:Jada Hamilton, PhD, MPH
Phone:646-888-0049

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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.

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.

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.

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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Jada Hamilton, PhD, MPH
Phone: 646-888-0049
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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