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Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00525655
First received: September 4, 2007
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Familial Adenomatous Polyposis
Colorectal Cancer
Behavioral: Web-Based Multimedia Intervention
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pilot Test FAP Website (Interviews) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant Assessment of FAP Website (Questionnaire) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: August 2007
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Survey

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.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525655

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525655     History of Changes
Other Study ID Numbers: 2006-1037, NCI-2011-02827
Study First Received: September 4, 2007
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Familial Adenomatous Polyposis
Colorectal Cancer
Multimedia Intervention
Questionnaire
Survey
FAP

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Colorectal Neoplasms
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014