Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tumor Genomic Profiling
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 495
- Locations
- 1
- Primary Endpoint
- The investigators will assess patients' emotional responses to receiving their secondary findings
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
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.