IFACT: Incidental Findings in Advanced Cancer Therapy (IFACT)
|ClinicalTrials.gov Identifier: NCT02217891|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment|
|Breast Cancer Colorectal Cancer Bladder Cancer Lung Cancer||Behavioral: Semi-structured interview|
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 Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||IFACT: Incidental Findings in Advanced Cancer Therapy|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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.
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.
- qualitive data [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217891
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jada Hamilton, PhD, MPH||Memorial Sloan Kettering Cancer Center|