Breast CancerNCT01686360
Communicating Objective Risk for Personalized Decision Making About Mammography
A study testing Decision Aid in people with Breast Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman… Read more about this study
- Who is it for?
- Ages 35 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 18 Dec 2012
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Who cannot join
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.
Read the detailed description
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
- Conditions
- Breast Cancer
- Being tested
- Decision Aid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control group 1: pre/post-test | No intervention | Group receives pre and post test questions only. |
| Control group 2: tool and pre/post-test | Experimental | Group receives decision tool without personalized information. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
| Gail score in a percentage format | Experimental | Group receives Gail score in a percentage format. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
| Gail score in a frequency format | Experimental | Group receives Gail score in a frequency format. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
| Frequency + Average 50 year old | Experimental | Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
| Frequency + Mammography Data | Experimental | Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
| Frequency + Mortality Data | Experimental | Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid) Receives: Behavioral: Decision Aid |
| Frequency + Avg 50 year old + Mamm Data + Mortality Data | Experimental | Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography. (Behavioral: Decision Aid) Receives: Behavioral: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral intentions to get a mammogram
All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
Measured: immediately following intervention (time 0)
Secondary outcomes (1)
Attitude about mammography
Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
Measured: immediately following intervention (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion18 Dec 2012
- Study completion18 Dec 2012
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 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph N Cappella, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686360
- Sponsor's protocol ID
- 816186
- Status last verified
- Jul 2017
- First submitted
- 28 Aug 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Objective Risk for Personalized Decision Making About Mammography
- ClinicalTrials.gov ID
- NCT01686360
- Acronym / sponsor ID
- 816186
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,560 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 18 Dec 2012 (actual)
- Study completion
- 18 Dec 2012 (actual)
- First posted
- 18 Sep 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 purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.
Detailed description
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control group 1: pre/post-test | No intervention | –Group receives pre and post test questions only. |
| Control group 2: tool and pre/post-test | Experimental | Behavioral: Decision AidGroup receives decision tool without personalized information. (Behavioral: Decision Aid) |
| Gail score in a percentage format | Experimental | Behavioral: Decision AidGroup receives Gail score in a percentage format. (Behavioral: Decision Aid) |
| Gail score in a frequency format | Experimental | Behavioral: Decision AidGroup receives Gail score in a frequency format. (Behavioral: Decision Aid) |
| Frequency + Average 50 year old | Experimental | Behavioral: Decision AidGroup receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman. (Behavioral: Decision Aid) |
| Frequency + Mammography Data | Experimental | Behavioral: Decision AidGroup receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid) |
| Frequency + Mortality Data | Experimental | Behavioral: Decision AidGroup receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid) |
| Frequency + Avg 50 year old + Mamm Data + Mortality Data | Experimental | Behavioral: Decision AidGroup receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography. (Behavioral: Decision Aid) |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Key exclusion criteria (1 listed)
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
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 |
|---|---|---|
| Decision Aid | Behavioural | Control group 2: tool and pre/post-test, Frequency + Average 50 year old, Frequency + Avg 50 year old + Mamm Data + Mortality Data, Frequency + Mammography Data, Frequency + Mortality Data, Gail score in a frequency format, Gail score in a percentage format |
Primary outcome
Behavioral intentions to get a mammogram
Time frame: immediately following intervention (time 0)
All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
1 secondary outcome
Attitude about mammography
Time frame: immediately following intervention (time 0)
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 21 Jul 2017.
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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.
Joseph N Cappella, 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 Decision Aid in people with Breast Cancer, 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 1 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 21 Jul 2017. 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?
Behavioral intentions to get a mammogram (time frame: immediately following intervention (time 0)). 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 21 Jul 2017.