IFACT: Incidental Findings in Advanced Cancer Therapy

NCT ID: NCT02217891

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2023-02-09

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)

Conditions

Breast Cancer; Colorectal Cancer; Bladder Cancer; Lung Cancer

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

participants from existing MSK protocol 12-245

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.

Semi-structured interview

Intervention Type: BEHAVIORAL

Pts will participate in a 45-60-minute, one-on-one, audio-recorded interview. They will be conducted over the telephone or in person at the MSK Counseling Center. They will be conducted in accordance with a semi-structured interview guide developed by our study team of experts in clinical genetics, health psychology, \& qualitative methodology. Topics to be covered in the interview include: 1) perceived potential benefits \& harms of tumor genomic profiling; 2) interest in \& perceived benefits \& harms of incidental findings arising from tumor genomic profiling; 3) anticipated process \& needs for decision-making about learning incidental findings; 4) interest in learning specific kinds of incidental findings (including those related to treatable diseases, different cancers, non-treatable diseases, \& those that only have meaning for family members); 5) preferences about sharing incidental findings with other people; \& 6) implications of \& concerns about incidental findings for family.

Interventions

Semi-structured interview

Pts will participate in a 45-60-minute, one-on-one, audio-recorded interview. They will be conducted over the telephone or in person at the MSK Counseling Center. They will be conducted in accordance with a semi-structured interview guide developed by our study team of experts in clinical genetics, health psychology, \& qualitative methodology. Topics to be covered in the interview include: 1) perceived potential benefits \& harms of tumor genomic profiling; 2) interest in \& perceived benefits \& harms of incidental findings arising from tumor genomic profiling; 3) anticipated process \& needs for decision-making about learning incidental findings; 4) interest in learning specific kinds of incidental findings (including those related to treatable diseases, different cancers, non-treatable diseases, \& those that only have meaning for family members); 5) preferences about sharing incidental findings with other people; \& 6) implications of \& concerns about incidental findings for family.

Intervention Type: BEHAVIORAL

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jada Hamilton, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-159

Identifier Type: -

Identifier Source: org_study_id