IFACT: Incidental Findings in Advanced Cancer Therapy

NCT02217891 | Completed

• 1 other identifier: 14-159
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Bladder Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Semi-structured interview 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.

participants from existing MSK protocol 12-245

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IFACT study participants will be recruited from existing MSK protocol #12-245.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Urinary Bladder Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jada Hamilton, PhD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

US (1)