IFACT: Incidental Findings in Advanced Cancer Therapy

Breast Cancer Clinical Trial

— IFACT  

Official title:

IFACT: Incidental Findings in Advanced Cancer Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217891
• Other study ID #: 14-159
• Status: Completed
• Start date: August 2014
• Est. completion date: February 9, 2023

Study information

• Verified date: February 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qualitive data	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).	one time

External Links

•   Memorial Sloan Kettering Cancer Center