Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00525655|
Recruitment Status : Active, not recruiting
First Posted : September 6, 2007
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Familial Adenomatous Polyposis Colorectal Cancer||Behavioral: Web-Based Multimedia Intervention Behavioral: Questionnaire||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)|
|Actual Study Start Date :||August 2007|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
|Experimental: Multimedia Intervention||
Behavioral: Web-Based Multimedia Intervention
Website designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes.
Questionnaires taking 10-15 minutes to complete.
Other Name: Survey
- Pilot Test FAP Website (Interviews) [ Time Frame: 2 years ]
- Participant Assessment of FAP Website (Questionnaire) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525655
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan Peterson, PhD||M.D. Anderson Cancer Center|