Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
Primary Purpose
Familial Adenomatous Polyposis, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-Based Multimedia Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Familial Adenomatous Polyposis focused on measuring Familial Adenomatous Polyposis, Colorectal Cancer, Multimedia Intervention, Questionnaire, Survey, FAP
Eligibility Criteria
Eligibility: (List All Criteria)
Inclusion Criteria:
- 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study.
- 18-21 year old with a previous cancer diagnosis.
- Able to read and speak English.
Exclusion Criteria:
1) n/a
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multimedia Intervention
Arm Description
Outcomes
Primary Outcome Measures
Pilot Test FAP Website (Interviews)
Secondary Outcome Measures
Participant Assessment of FAP Website (Questionnaire)
Full Information
NCT ID
NCT00525655
First Posted
September 4, 2007
Last Updated
March 19, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00525655
Brief Title
Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
Official Title
Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2007 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Adenomatous Polyposis, Colorectal Cancer
Keywords
Familial Adenomatous Polyposis, Colorectal Cancer, Multimedia Intervention, Questionnaire, Survey, FAP
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimedia Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Web-Based Multimedia Intervention
Intervention Description
Website designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Questionnaires taking 10-15 minutes to complete.
Primary Outcome Measure Information:
Title
Pilot Test FAP Website (Interviews)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Participant Assessment of FAP Website (Questionnaire)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility: (List All Criteria)
Inclusion Criteria:
1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study.
18-21 year old with a previous cancer diagnosis.
Able to read and speak English.
Exclusion Criteria:
1) n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Peterson, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
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