IFACT: Incidental Findings in Advanced Cancer Therapy

Completed

• Conditions: Bladder Cancer; Lung Cancer; Breast Cancer; Colorectal Cancer
• Interventions: Behavioral: Semi-structured interview

• Registration Number: NCT02217891
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this research gap by examining MSK patients' attitudes, preferences, and information needs regarding incidental findings arising from tumor genomic profiling.

Detailed Description

Part 1, the investigators will recruit 40 participants from those already enrolled in existing MSK IRB protocol #12-245 (PI: David Hyman, MD) including male and female patients who have been diagnosed with late-stage breast, colorectal, bladder, and lung cancer (some of the most common cancers in this study population).

Part 2, the investigators will recruit 20 participants from those who have actually received incidental germline findings from MSK IRB protocol #12-245 Consent Part C in order to cognitively test novel survey items about their knowledge and perceived utility of their incidental findings (note that the content of these items will be derived from the data collected in Part 1)

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Status Verified: 2023-02
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Part 1:

• Patient enrolled on MSK protocol #12-245
• Living patient age 18 or older
• Patient diagnosed with breast cancer, colorectal cancer, bladder cancer, or lung cancer
• Patient residing in New York metro-area

Part 2:

• Living patient age 18 or older
• Consented to Part C of IRB#12-245 and has received results regardless if thereir was a pathogenic variant
• Patient diagnosed with cancer type approved for IRB#12-245 Part C (which are currently breast cancer, gynecological cancer, prostate cancer, and GU non-prostate cancer)breast cancer, colorectal cancer, bladder cancer, or lung cancer
• Patient residing in New York metro-area

Exclusion Criteria for Part 1 and 2:

• Non-English speakers because we do not have the resources to conduct and translate the interviews into other languages.
• Patient unwilling or unable to provide informed consent.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participants from existing MSK protocol 12-245	Semi-structured interview	Participants' responses regarding the benefits and harms of incidental findings arising from tumor genomic profiling will be used to generate novel questionnaire items to assess the construct of perceived personal and clinical utility, which will be tested, along with items designed to assess knowledge about tumor genomic profiling and incidental findings. Part 2, the investigators will conduct 30-minute cognitive interviews to assess participants' understanding and opinions about the novel items designed to assess perceived personal and clinical utility of incidental findings and knowledge about incidental findings arising from tumor genomic profiling.

Primary Outcome Measures

Name	Time	Method
qualitive data	one time	The study team will review and code the interview transcripts through a process of independent and collaborative thematic content analysis,(25-28) using ATLAS.ti (a qualitative data analysis software package) to facilitate the analysis process (29).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States