Development of a measure of self-concept in youth diagnosed with FAP
(P.I. Dr. Mary Jane Esplen)
Protocol Summary
- Objective: The purpose of this study is to develop and validate an instrument for measuring the impact of being diagnosed with Familial Adenomatous Polyposis (FAP) on an adolescent's self-concept.
- Importance of self-concept in maintaining physical & psychosocial wellbeing has been recognized in youths and adults. Potential negative psychological labeling associated with the diagnosis of an illness or other fear-arousing information may impact a person's self-concept & play a role in health behaviors.
- Global measures of self-concept may be less relevant for capturing the specific self-descriptors associated with the experience of being diagnosed with FAP at a young age. Valid & reliable quantitative measures designed for these populations are required. A new and validated measure of self-concept has potential use as a clinical screening and research tool that could enhance counseling & future studies on the psychological impact of FAP.
- Methodology: The method of scale development is based on the multi-stage method of Jackson (1970) that takes validation into consideration at each stage of development.
- Instrumentation includes 36-item candidate scale (5 point Likert scale) and the following standardized validating measures: Pier-Harris 2 Children's Self-Concept Scale, Ladder Quality of Life Scale (visual analogue), Marlowe-Crowne Social Desirability Scale (short-form), Rosenberg Self Esteem Scale. The survey is a one-time mail out and takes approximately 30 minutes to complete.
- Inclusion criteria: a) adolescent male or female b) diagnosed with Familial Adenomous Polyposis c) assent/ informed consent for psychosocial study, and d) age 12 to 18 years. Note: we interested in those that have undergone genetic testing or preventative surgery as well as those who have not. Exclusion criteria: a) Too ill to complete measures, b) refusal to provide informed consent, and c) non-understanding of written English.
- Sample: We have based our sample size calculations on a 5:1 subject/item ratio. Recruitment of approximately 160 - 180 adolescents is needed to complete initial validation of the scale. Participating sites include: the Familial GI Cancer Registry (Ontario, Canada); the University of California at San Francisco Medical Center (San Francisco, CA); the Cleveland Clinic Registry (Cleveland, US) and the St. Mark's Hospital (UK).
- Ethics: Participation in this study may cause individuals to focus more directly on their reactions to the diagnosis of FAP. We have mechanisms in place where individual questions or concerns can be responded to by psychosocial personnel responsible for the study. In our experience, most of the questions or concerns about the study can be effectively managed in this way. If there are additional concerns, the study PI will arrange for an individual interview in order to fully discuss and resolve any difficulties. Benefits may include the opportunity to provide direct feedback on the testing process as it occurs as well as assisting clinicians and researchers in better understanding the personal impact of FAP diagnosis and genetic testing in order to develop programs and services in the future.
- All questionnaire packages are pre-coded with individual study numbers or numeric codes that do not identify the individual involved in the study. The data is entered into a secure and confidential database and hard copies are stored in a locked filling cabinet in a secure research office.
- The study protocol has received ethics approval from the University of Toronto Human Subjects Committee, the University of California at San Francisco Medical Center, the Cleveland Clinic Foundation and St. Mark's Hospital.
For further information please contact:
Terri Berk, MSSA
Clinical Co-ordinator
Dr. Zane Cohen Digestive Diseases
Clinical Research Centre
Mount Sinai Hospital
Joseph and Wolf Lebovic Health Complex
L3-024, 60 Murray Street
Toronto ON, M5T 3L9
t 416-586-4800 ext. 8334
f 416-586-5924
e tberk@mtsinai.on.ca
www.mtsinai.ca/care/fgicr