Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)

study id #: NCT00525655

condition: Familial Adenomatous Polyposis, Colorectal Cancer

status: active, not recruiting

The goal of this research study is to test the first version of a website that will offer information and support for adolescents and young adults with FAP. Researchers want to see if the website will be helpful, easy to understand, and easy to use for young patients with FAP.

intervention:
Behavioral: Web-Based Multimedia Intervention
Behavioral: Questionnaire

start date: August 2007

estimated completion: February 28, 2020

last updated: January 2, 2020

phase of development: Not Available

size / enrollment: 55

study design:
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

study description:
Study Participation:
If you agree to take part in this study, you will view the website, take part in a one-on-one interview or a small group discussion (a focus group), and one or more questionnaires. You may come to M. D. Anderson to take part in this study, which may take place during your routine doctor visit, if this is possible. If you are enrolled in a registry outside of M. D. Anderson, or if you do not wish to come to M. D. Anderson, you will access the website over the internet.
You will be asked to fill out a brief knowledge and quality of life questionnaire that will take 10-15 minutes to complete. For the website, you will be asked to view (all or parts) of an early version. The website is designed to offer information and support for adolescents and young adults with FAP. Viewing the website will take about 30-60 minutes, depending on what stage of development the website is in at the time.
For the one-on-one interview or focus group (after viewing the website), you will speak with a research assistant. You will be asked for your permission to record this interview or focus group on an audiotape so that study staff can collect all of your responses. During this interview or focus group, you will be asked about different aspects of the website, including if you like it, if the information is useful to you, and if the website is easy to understand and use. You will also be asked about ways that you think the website can be improved or changed to better serve adolescents and young adults patients with FAP. This interview or focus group will take about 15-30 minutes to complete.
For the questionnaire, some participants (those who view later versions of the website) will also be asked to complete the Website Analysis and Measurement Inventory (WAMMI). The WAMMI is a questionnaire that will measure if the website is appealing and easy to use for adolescents and young adults patients with FAP. Examples of questions on the WAMMI will be about whether you can quickly find what you want on the website and whether everything on this website easy to understand. You will be able to answer the questions on a 5-point scale from "Strongly Agree" to "Strongly Disagree." The questionnaire will take about 5-10 minutes to complete.
After you have finished viewing the website and completed the interview (and/or questionnaire), you will be given the option to speak with a genetic counselor if you have any questions about FAP.
Length of Study:
Your total time on this study will range from about 45 minutes to 2 hours. Your participation will be over in this study once you have finished viewing the website and completed the interview and/or questionnaire.
This is an investigational study. Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.

primary outcomes:

• Pilot Test FAP Website (Interviews) [ Time Frame:2 years ]

secondary outcomes:

• Participant Assessment of FAP Website (Questionnaire) [ Time Frame:2 years ]

inclusion criteria:

exclusion criteria:

sponsor: M.D. Anderson Cancer Center

investigators: Susan Peterson, PhD

trial center locations: United States

• United States, Texas
  University of Texas MD Anderson Cancer Center