Familial Adenomatous PolyposisNCT00525655
Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
A study testing Web-Based Multimedia Intervention and Questionnaire in people with Familial Adenomatous Polyposis and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Familial Adenomatous Polyposis, Colorectal Cancer
- What is being tested?
- Web-Based Multimedia Intervention and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1) n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Familial Adenomatous Polyposis, Colorectal Cancer
- Being tested
- Web-Based Multimedia Intervention, Questionnaire
- Keywords
- Familial Adenomatous Polyposis, Colorectal Cancer, Multimedia Intervention, Questionnaire, Survey, FAP
- Medical subject headings
- Adenomatous Polyposis Coli, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Multimedia InterventionBehavioural
Website designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 10-15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia Intervention | Experimental | Not described Receives: Behavioral: Web-Based Multimedia Intervention; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot Test FAP Website (Interviews)
Measured: 2 years
Secondary outcomes (1)
Participant Assessment of FAP Website (Questionnaire)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startAug 2007
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525655
- Sponsor's protocol ID
- 2006-1037
- Other IDs
- NCI-2011-02827, 1R41CA126453-01A1
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2007
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)
- ClinicalTrials.gov ID
- NCT00525655
- Acronym / sponsor ID
- 2006-1037
- Conditions
- Familial Adenomatous Polyposis, Colorectal Cancer
- Keywords
- Familial Adenomatous Polyposis, Colorectal Cancer, Multimedia Intervention, Questionnaire, Survey, FAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimedia Intervention | Experimental | Behavioral: Web-Based Multimedia Intervention, Behavioral: Questionnaire |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Multimedia InterventionWebsite designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes. | Behavioural | Multimedia Intervention |
| QuestionnaireAlso: SurveyQuestionnaires taking 10-15 minutes to complete. | Behavioural | Multimedia Intervention |
Primary outcome
Pilot Test FAP Website (Interviews)
Time frame: 2 years
1 secondary outcome
Participant Assessment of FAP Website (Questionnaire)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Peterson, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Multimedia Intervention and Questionnaire in people with Familial Adenomatous Polyposis and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot Test FAP Website (Interviews) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.