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IFACT: Incidental Findings in Advanced Cancer Therapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02217891
First received: August 13, 2014
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Bladder Cancer
Lung Cancer
Behavioral: Semi-structured interview

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: IFACT: Incidental Findings in Advanced Cancer Therapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • qualitive data [ Time Frame: one time ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 24
Study Start Date: August 2014
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
participants from existing MSK protocol 12-245 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02217891

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jada Hamilton, PhD, MPH Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02217891     History of Changes
Other Study ID Numbers: 14-159
Study First Received: August 13, 2014
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Urinary Bladder Neoplasms
Breast Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Urologic Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Skin Diseases
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 23, 2014