Hereditary DiseasesNCT01645904
A Social Media Approach to Improve Genetic Risk Communication Phase I
An observational study of Hereditary Diseases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to create an internet-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Diseases
- What is being tested?
- Audiotaped Focus Group, Demographic Questionnaire and Audiotaped Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited from Lynch syndrome families enrolled in the Human Pedigree Analysis Resource (HPAR), MDACC's hereditary cancer registry.
Who may be able to join
- At least 18 years of age
- Able to read and speak english
- Completion of genetic counseling and testing for a Lynch syndrome mutation
- Persons with positive (i.e., carrier of Lynch syndrome MMR mutation) as well as indeterminate test results
Who cannot join
- 1) None
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 create an internet-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome.
Read the detailed description
If you agree to take part in this study, you will be assigned to 1 of 3 groups based on when you joined the study.
Group 1:
If you are assigned to Group 1, you will take part in a focus group where you will be asked what you would want in a web-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome. You will also fill out a questionnaire with questions about your demographics (age, race, marital status) and your medical history. This visit should take about 1 hour to complete.
Group 2:
If you are assigned to Group 2, you will come to the Behavioral Research and Treatment Center (BRTC) at MD Anderson to use the initial version of the My Family Garden website. My Family Garden is designed to teach new ways of communicating about Lynch Syndrome and about other issues related to the disease (such as risks associated with the disease, etc.). You will be instructed on how to use the program by the study staff. After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out a questionnaire called the Website Analysis and MeasureMent Inventory (WAMMI) which is designed help rate websites. You will also fill out the demographics questionnaire described above.
You will be given the option of completing the WAMMI and demographics questionnaire at the BRTC after your session or at your home. If you choose to complete them at home, you will be provided with a self-addressed, postage-paid envelope so you can mail the questionnaires back to the study staff.
This visit should take about 90 minutes to complete.
Group 3:
If you are assigned to Group 3, you will use the final version of the My Family Garden website. This final version will include changes from the web designers after feedback has been given from the previous groups in this study.
After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out the WAMMI questionnaire and demographics questionnaire described above.
You will be given the option of coming to the BRTC at MD Anderson to use the My Family Garden computer program or using the program from your home. If you choose to use My Family Garden from your home, you will be given a secure, password-protected hyperlink via e-mail to access the program. You will be instructed on how to use the program by the study staff either in person or over the phone. If you use the program from your home, the study staff will give the interview over the phone. If you complete the questionnaire at your home, you will be provided with a self-addressed, postage-paid envelope so you can mail it back to the study staff.
Whether it is completed at MD Anderson or at home, this visit should last about 90 minutes.
Audiotapes:
All focus groups and interviews will be audiotaped. The audiotapes collected during the course of this study will be stored in locked file cabinets in a locked office and will be destroyed after 5 years.
Length of Study Participation:
Your participation in this study will be over after you have completed the study procedures described above.
This is an investigational study.
Up to 49 participants will be enrolled in this study. All participants will be enrolled at MD Anderson.
- Conditions
- Hereditary Diseases
- Being tested
- Audiotaped Focus Group, Demographic Questionnaire, Audiotaped Interview, WAMMI Inventory
- Keywords
- Hereditary Diseases, Genetic, Lynch syndrome, Positive or indeterminate test results for Lynch syndrome, Social media, Internet-based program, Questionnaire, Survey, My Family Garden website, Interview, Focus group, Website Analysis and MeasureMent Inventory, WAMMI
- Medical subject headings
- Genetic Diseases, Inborn, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiotaped Focus GroupBehavioural
Participation in a focus group regarding web-based program designed to improve communication of health and health history information among family members affected by Lynch syndrome.
Demographic QuestionnaireBehavioural
Also called Surveys
Complete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete.
Audiotaped InterviewBehavioural
Group 2: Patients provide feedback regarding initial version of My Family Garden website.
Group 3: Patients provide feedback regarding final version of My Family Garden website.
WAMMI InventoryBehavioural
Patients complete Website Analysis and MeasureMent Inventory. This visit should take about 90 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients participate in audiotaped focus group regarding web-based program, and fill out demographics questionnaire. Receives: Behavioral: Audiotaped Focus Group; Behavioral: Demographic Questionnaire | |
| Group 2 | Patients come to Behavioral Research and Treatment Center (BRTC) at MD Anderson to use initial version of My Family Garden website. Completion of Website Analysis and MeasureMent Inventory (WAMMI), and demographics questionnaires. Receives: Behavioral: Demographic Questionnaire; Behavioral: Audiotaped Interview; Behavioral: WAMMI Inventory | |
| Group 3 | Patients use final version of My Family Garden website, and are interviewed which will be audiotaped. Completion of Website Analysis and MeasureMent Inventory (WAMMI), questionnaire and demographics questionnaire. Receives: Behavioral: Demographic Questionnaire; Behavioral: Audiotaped Interview; Behavioral: WAMMI Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Internet-Based Program Among Lynch Syndrome Family Members
Quantitative analysis include descriptive statistics summarizing participants' demographic and clinical characteristics. Descriptive statistics calculated for each subscale of Website Analysis and MeasureMent Inventory (WAMMI) and for overall measure. Focus groups and interviews transcribed, coded and analyzed. Responses sorted into categorical and conceptual groups, field notes taken during user testing also used to aid in interpretation of interview data.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary DiseasesStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Duncan Family Institute
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, MPH, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645904
- Sponsor's protocol ID
- 2012-0418
- Status last verified
- May 2019
- First submitted
- 18 Jul 2012
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Social Media Approach to Improve Genetic Risk Communication Phase I
- ClinicalTrials.gov ID
- NCT01645904
- Acronym / sponsor ID
- 2012-0418
- Conditions
- Hereditary Diseases
- Keywords
- Hereditary Diseases, Genetic, Lynch syndrome, Positive or indeterminate test results for Lynch syndrome, Social media, Internet-based program, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Duncan Family Institute
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 20 Jul 2012 (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 create an internet-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome.
Detailed description
If you agree to take part in this study, you will be assigned to 1 of 3 groups based on when you joined the study.
Group 1:
If you are assigned to Group 1, you will take part in a focus group where you will be asked what you would want in a web-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome. You will also fill out a questionnaire with questions about your demographics (age, race, marital status) and your medical history. This visit should take about 1 hour to complete.
Group 2:
If you are assigned to Group 2, you will come to the Behavioral Research and Treatment Center (BRTC) at MD Anderson to use the initial version of the My Family Garden website. My Family Garden is designed to teach new ways of communicating about Lynch Syndrome and about other issues related to the disease (such as risks associated with the disease, etc.). You will be instructed on how to use the program by the study staff. After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out a questionnaire called the Website Analysis and MeasureMent Inventory (WAMMI) which is designed help rate websites. You will also fill out the demographics questionnaire described above.
You will be given the option of completing the WAMMI and demographics questionnaire at the BRTC after your session or at your home. If you choose to complete them at home, you will be provided with a self-addressed, postage-paid envelope so you can mail the questionnaires back to the study staff.
This visit should take about 90 minutes to complete.
Group 3:
If you are assigned to Group 3, you will use the final version of the My Family Garden website. This final version will include changes from the web designers after feedback has been given from the previous groups in this study.
After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out the WAMMI questionnaire and demographics questionnaire described above.
You will be given the option of coming to the BRTC at MD Anderson to use the My Family Garden computer program or using the program from your home. If you choose to use My Family Garden from your home, you will be given a secure, password-protected hyperlink via e-mail to access the program. You will be instructed on how to use the program by the study staff either in person or over the phone. If you use the program from your home, the study staff will give the interview over the phone. If you complete the questionnaire at your home, you will be provided with a self-addressed, postage-paid envelope so you can mail it back to the study staff.
Whether it is completed at MD Anderson or at home, this visit should last about 90 minutes.
Audiotapes:
All focus groups and interviews will be audiotaped. The audiotapes collected during the course of this study will be stored in locked file cabinets in a locked office and will be destroyed after 5 years.
Length of Study Participation:
Your participation in this study will be over after you have completed the study procedures described above.
This is an investigational study.
Up to 49 participants will be enrolled in this study. All participants will be enrolled at MD Anderson.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Audiotaped Focus Group, Behavioral: Demographic QuestionnairePatients participate in audiotaped focus group regarding web-based program, and fill out demographics questionnaire. |
| Group 2 | – | Behavioral: Demographic Questionnaire, Behavioral: Audiotaped Interview, Behavioral: WAMMI InventoryPatients come to Behavioral Research and Treatment Center (BRTC) at MD Anderson to use initial version of My Family Garden website. Completion of Website Analysis and MeasureMent Inventory (WAMMI), and demographics questionnaires. |
| Group 3 | – | Behavioral: Demographic Questionnaire, Behavioral: Audiotaped Interview, Behavioral: WAMMI InventoryPatients use final version of My Family Garden website, and are interviewed which will be audiotaped. Completion of Website Analysis and MeasureMent Inventory (WAMMI), questionnaire and demographics questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited from Lynch syndrome families enrolled in the Human Pedigree Analysis Resource (HPAR), MDACC's hereditary cancer registry.
Key inclusion criteria (4 listed)
- At least 18 years of age
- Able to read and speak english
- Completion of genetic counseling and testing for a Lynch syndrome mutation
- Persons with positive (i.e., carrier of Lynch syndrome MMR mutation) as well as indeterminate test results
Key exclusion criteria (1 listed)
- 1) None
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 |
|---|---|---|
| Audiotaped Focus GroupParticipation in a focus group regarding web-based program designed to improve communication of health and health history information among family members affected by Lynch syndrome. | Behavioural | Group 1 |
| Demographic QuestionnaireAlso: SurveysComplete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete. | Behavioural | Group 1, Group 2, Group 3 |
| Audiotaped InterviewGroup 2: Patients provide feedback regarding initial version of My Family Garden website. Group 3: Patients provide feedback regarding final version of My Family Garden website. | Behavioural | Group 2, Group 3 |
| WAMMI InventoryPatients complete Website Analysis and MeasureMent Inventory. This visit should take about 90 minutes to complete. | Behavioural | Group 2, Group 3 |
Primary outcome
Evaluation of Internet-Based Program Among Lynch Syndrome Family Members
Time frame: 1 day
Quantitative analysis include descriptive statistics summarizing participants' demographic and clinical characteristics. Descriptive statistics calculated for each subscale of Website Analysis and MeasureMent Inventory (WAMMI) and for overall measure. Focus groups and interviews transcribed, coded and analyzed. Responses sorted into categorical and conceptual groups, field notes taken during user testing also used to aid in interpretation of interview data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- 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, MPH, 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?
An observational study of Hereditary Diseases, 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 4 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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?
Results are not available in the source record.
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?
Evaluation of Internet-Based Program Among Lynch Syndrome Family Members (time frame: 1 day). 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 28 May 2019.