IFACT: Incidental Findings in Advanced Cancer Therapy

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Bladder Cancer; Lung Cancer; Colorectal Cancer

Treatments: Behavioral: Semi-structured interview

Study type: Observational

Funder types: Other

Identifiers

NCT02217891

14-159

Details and patient eligibility

About

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.

Full 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)

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

60 participants in 1 patient group

participants from existing MSK protocol 12-245

Description:

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.

Treatment:

Behavioral: Semi-structured interview