Breast CancerNCT00525980
Cancer Genetics CD-ROM for Hispanics
A study testing Computer Program, Focus Group and Written Materials in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This project will build upon prior, successful research on the effectiveness of an interactive computer disk with readable only memory (CD-ROM) for educating women about breast cancer and genetic risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Computer Program, Focus Group and Written Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Mar 2013
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residing in the El Paso metropolitan area and self-identifying as Hispanic
- Being 18 years of age or older
- Women who have a personal history of breast cancer or have a first-degree relative with breast cancer OR lay health workers (male or female)
- Able to provide informed consent
Who cannot join
- Having a primary language other than English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Cancer and Chronic Disease Consortium (CCDC) of El Paso
El Paso, Texas, 79905
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Interactive CD-ROM on Cancer Genetics for Hispanics
This project will build upon prior, successful research on the effectiveness of an interactive computer disk with readable only memory (CD-ROM) for educating women about breast cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women about breast cancer risk and genetic testing was effective. The program was well received by lay persons and professionals. In a randomized controlled trial conducted at multiple sites, the CD-ROM intervention was highly effective in increasing knowledge, especially among women at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.
Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways. The overall goal of this proposal is to evaluate the program as a first-line educational approach for Hispanic women on the Texas-Mexico border, where educational resources about cancer genetics are limited. First, researchers will modify and adapt the program for a primarily Hispanic population, in order to make it culturally and linguistically appropriate to the needs of that audience.
Read more
Second, researchers will evaluate the program as a first-line educational method among women with a personal or family history of breast cancer. Researchers will compare the effectiveness of the CD-ROM when implemented with and without the guidance of a trained promotora, and in comparison with standard educational materials (usual care condition).
The specific aims of this study include:
Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current knowledge about breast cancer genetics; c) add a module to help women prepare to discuss their family history and cancer risk with a health care provider (n=50 participants).
Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard written materials (n=414 participants).
Read the detailed description
This study will test ways to help improve Hispanic women's knowledge and understanding about breast cancer risk and genetic testing for inherited cancer risk. These methods include providing printed educational materials, using an educational computer program, and using the computer program with the assistance of a lay health worker (a promotora).
If you agree to take part in this study, you will complete a questionnaire that will ask about your personal health as well as your knowledge and attitudes toward cancer and genetic testing. After the questionnaire is completed, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. One group will be asked to read educational materials. Another group will use an educational computer program to learn about breast cancer risk and genetic testing without guidance. Another group will use the computer program with the guidance of a promotora.
Each of the 3 study groups should take between 30 and 60 minutes to complete.
Immediately after participating in your assigned group, you will be asked to complete another questionnaire that will ask about your knowledge and attitudes toward cancer and genetic testing. You will also be contacted later by telephone to complete similar questionnaires at about 1 month and 6 months after your study visit. Some women will be asked to complete an additional questionnaire by telephone 1 week after reading the educational materials or the computer program, and researchers will ask for permission to audiotape this interview. It will take about 20 minutes to complete each of the questionnaires used in this study.
This is an investigational study. Up to 414 women will take part in this study.
- Conditions
- Breast Cancer
- Being tested
- Computer Program, Focus Group, Written Materials, Questionnaires
- Keywords
- Breast Cancer, Cancer Risk, CD-ROM, Focus Group, Cancer Genetics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer ProgramBehavioural
Participants will be given a program to learn about breast cancer risk and genetic testing.
Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor).
Focus GroupBehavioural
Focus group discussion lasting about 60 to 90 minutes.
Written MaterialsOther
Printed materials will be given. The CD-ROM will be offered at the end of the study.
QuestionnairesBehavioural
Also called Survey
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Written Materials | Experimental | One group asked to read educational materials. Receives: Behavioral: Focus Group; Other: Written Materials; Behavioral: Questionnaires |
| Group 2: Computer Program Only | Experimental | Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance. Receives: Behavioral: Computer Program; Behavioral: Focus Group; Behavioral: Questionnaires |
| Group 3: Computer Program + Promotora | Experimental | Group 3 use the computer program with the guidance of a promotora. Receives: Behavioral: Computer Program; Behavioral: Focus Group; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data analysis of structured questionnaires
Measured: 3 Years
Secondary outcomes (1)
Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
Measured: 3 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 startFeb 2007
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525980
- Sponsor's protocol ID
- 2006-0339
- Status last verified
- Apr 2013
- First submitted
- 4 Sep 2007
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive CD-ROM on Cancer Genetics for Hispanics
- ClinicalTrials.gov ID
- NCT00525980
- Acronym / sponsor ID
- 2006-0339
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cancer Risk, CD-ROM, Focus Group, Cancer Genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)
- Study start
- Feb 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (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.
This project will build upon prior, successful research on the effectiveness of an interactive computer disk with readable only memory (CD-ROM) for educating women about breast cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women about breast cancer risk and genetic testing was effective. The program was well received by lay persons and professionals. In a randomized controlled trial conducted at multiple sites, the CD-ROM intervention was highly effective in increasing knowledge, especially among women at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.
Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways. The overall goal of this proposal is to evaluate the program as a first-line educational approach for Hispanic women on the Texas-Mexico border, where educational resources about cancer genetics are limited. First, researchers will modify and adapt the program for a primarily Hispanic population, in order to make it culturally and linguistically appropriate to the needs of that audience.
Second, researchers will evaluate the program as a first-line educational method among women with a personal or family history of breast cancer. Researchers will compare the effectiveness of the CD-ROM when implemented with and without the guidance of a trained promotora, and in comparison with standard educational materials (usual care condition).
The specific aims of this study include:
Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current knowledge about breast cancer genetics; c) add a module to help women prepare to discuss their family history and cancer risk with a health care provider (n=50 participants).
Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard written materials (n=414 participants).
Detailed description
This study will test ways to help improve Hispanic women's knowledge and understanding about breast cancer risk and genetic testing for inherited cancer risk. These methods include providing printed educational materials, using an educational computer program, and using the computer program with the assistance of a lay health worker (a promotora).
If you agree to take part in this study, you will complete a questionnaire that will ask about your personal health as well as your knowledge and attitudes toward cancer and genetic testing. After the questionnaire is completed, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. One group will be asked to read educational materials. Another group will use an educational computer program to learn about breast cancer risk and genetic testing without guidance. Another group will use the computer program with the guidance of a promotora.
Each of the 3 study groups should take between 30 and 60 minutes to complete.
Immediately after participating in your assigned group, you will be asked to complete another questionnaire that will ask about your knowledge and attitudes toward cancer and genetic testing. You will also be contacted later by telephone to complete similar questionnaires at about 1 month and 6 months after your study visit. Some women will be asked to complete an additional questionnaire by telephone 1 week after reading the educational materials or the computer program, and researchers will ask for permission to audiotape this interview. It will take about 20 minutes to complete each of the questionnaires used in this study.
This is an investigational study. Up to 414 women will take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Written Materials | Experimental | Behavioral: Focus Group, Other: Written Materials, Behavioral: QuestionnairesOne group asked to read educational materials. |
| Group 2: Computer Program Only | Experimental | Behavioral: Computer Program, Behavioral: Focus Group, Behavioral: QuestionnairesGroup 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance. |
| Group 3: Computer Program + Promotora | Experimental | Behavioral: Computer Program, Behavioral: Focus Group, Behavioral: QuestionnairesGroup 3 use the computer program with the guidance of a promotora. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residing in the El Paso metropolitan area and self-identifying as Hispanic
- Being 18 years of age or older
- Women who have a personal history of breast cancer or have a first-degree relative with breast cancer OR lay health workers (male or female)
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Having a primary language other than English or Spanish
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 |
|---|---|---|
| Computer ProgramParticipants will be given a program to learn about breast cancer risk and genetic testing. Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor). | Behavioural | Group 2: Computer Program Only, Group 3: Computer Program + Promotora |
| Focus GroupFocus group discussion lasting about 60 to 90 minutes. | Behavioural | Group 1: Written Materials, Group 2: Computer Program Only, Group 3: Computer Program + Promotora |
| Written MaterialsPrinted materials will be given. The CD-ROM will be offered at the end of the study. | Other | Group 1: Written Materials |
| QuestionnairesAlso: SurveyOccasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing. | Behavioural | Group 1: Written Materials, Group 2: Computer Program Only, Group 3: Computer Program + Promotora |
Primary outcome
Data analysis of structured questionnaires
Time frame: 3 Years
1 secondary outcome
Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
Time frame: 3 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 10 Apr 2013.
- UT 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Program, Focus Group and Written Materials in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites 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: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Data analysis of structured questionnaires (time frame: 3 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 10 Apr 2013.