Breast Cancer PreventionNCT01299623
Breast Cancer Prevention Education
A study testing Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors in people with Breast Cancer Prevention, run by University of Pennsylvania at 1 site in United States.
Trial summary
We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention
- What is being tested?
- Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2014
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American women
- Ages 35-70
- No personal history of cancer
- Resident of Philadelphia metropolitan area
Who cannot join
- Non-African American
- Male
- Under 35 or over 70 years of age
- Personal history of cancer
- Not a resident of Philadelphia Metropolitan Area
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Community Based Research and Health Disparities
Philadelphia, Pennsylvania, 19104
About this study
Official title: Disseminating Breast Cancer Prevention to African American Women
We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:
- To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
- To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.
- Conditions
- Breast Cancer Prevention
- Being tested
- Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors
- Keywords
- breast cancer, breast cancer prevention, African American women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviorsBehavioural
Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.
| Study group | Role | What they receive |
|---|---|---|
| Evidential Group | Active comparator | Participants in this group will receive education about breast cancer prevention and specific information about African American women and breast cancer risk. Receives: Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors |
| Non-Evidential Group | Active comparator | Participants in this group will receive general information about breast cancer prevention without anything specific to African American women. Receives: Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention uptake
Assessment of participants' attendance at a session.
Measured: 1 session
knowledge about breast cancer prevention
Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.
Measured: 6 months
Communication about breast cancer prevention
Assessment of the extent to which women discuss breast cancer prevention with their health care providers at three and six months post intervention compared to at baseline.
Measured: 6 months
Distrust of medical research
Assessment of the extent to which participants harbor distrust for the medical establishment three and six months post intervention compared to at baseline.
Measured: 6 months
Secondary outcomes (3)
Education
Assessment of the relationship between participants' education and primary outcomes.
Measured: baseline
Family history
Assessment of the relationship between participants' family history and the primary outcomes.
Measured: baseline
Beliefs about research
Assessment of the relationship between participants' beliefs about research and the primary outcomes.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanita H Halbert, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299623
- Sponsor's protocol ID
- 1R18HSO19339-01
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2011
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating Breast Cancer Prevention to African American Women
- ClinicalTrials.gov ID
- NCT01299623
- Acronym / sponsor ID
- 1R18HSO19339-01
- Conditions
- Breast Cancer Prevention
- Keywords
- breast cancer, breast cancer prevention, African American women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Feb 2011 (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.
We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:
- To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
- To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidential Group | Active comparator | Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviorsParticipants in this group will receive education about breast cancer prevention and specific information about African American women and breast cancer risk. |
| Non-Evidential Group | Active comparator | Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviorsParticipants in this group will receive general information about breast cancer prevention without anything specific to African American women. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American women
- Ages 35-70
- No personal history of cancer
- Resident of Philadelphia metropolitan area
Key exclusion criteria (5 listed)
- Non-African American
- Male
- Under 35 or over 70 years of age
- Personal history of cancer
- Not a resident of Philadelphia Metropolitan Area
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 |
|---|---|---|
| Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviorsParticipants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention. | Behavioural | Evidential Group, Non-Evidential Group |
Primary outcome
Intervention uptake
Time frame: 1 session
Assessment of participants' attendance at a session.
knowledge about breast cancer prevention
Time frame: 6 months
Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.
Communication about breast cancer prevention
Time frame: 6 months
Assessment of the extent to which women discuss breast cancer prevention with their health care providers at three and six months post intervention compared to at baseline.
Distrust of medical research
Time frame: 6 months
Assessment of the extent to which participants harbor distrust for the medical establishment three and six months post intervention compared to at baseline.
3 secondary outcomes
Education
Time frame: baseline
Family history
Time frame: baseline
Beliefs about research
Time frame: baseline
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 19 Aug 2016.
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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.
Chanita H Halbert, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors in people with Breast Cancer Prevention, run by University of Pennsylvania 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 5 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 19 Aug 2016. 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?
Intervention uptake (time frame: 1 session). The study lists 4 primary outcomes in all. 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 19 Aug 2016.