Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Familial Adenomatous Polyposis
• Intervention / Treatment: Behavioral: Web-Based Multimedia Intervention; Behavioral: Questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Eligibility: (List All Criteria)

Inclusion Criteria:

1. 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study.
2. 18-21 year old with a previous cancer diagnosis.
3. Able to read and speak English.

Exclusion Criteria:

1) n/a

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Behavioral: Questionnaire; Questionnaires taking 10-15 minutes to complete.; Other Names: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pilot Test FAP Website (Interviews)	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Participant Assessment of FAP Website (Questionnaire)	2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Peterson, PhD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: September 4, 2007
• First Submitted That Met QC Criteria: September 5, 2007
• First Posted (Estimate): September 6, 2007

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Questionnaire; Survey; Colorectal Cancer; Familial Adenomatous Polyposis; FAP; Multimedia Intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Syndromes, Hereditary; Adenomatous Polyps; Adenoma; Intestinal Polyposis; Nasopharyngeal Neoplasms; Colorectal Neoplasms; Adenomatous Polyposis Coli
• Other Study ID Numbers: 2006-1037; NCI-2011-02827 (Registry Identifier: NCI CTRP); 1R41CA126453-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No