Breast CancerNCT01879189
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
A study testing Breast Cancer Screening Decision Aid in people with Breast Cancer, run by University of Pennsylvania at 9 sites in United States.
Trial summary
In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. Read more about this study
- Who is it for?
- Ages 39 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer Screening Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,302 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2013to Nov 2017
- 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 39 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ages 39-48
- Patient of one of the nine primary care or OB/GYN practices that are participating in the study
- Must have had an appointment at one of these locations in the past 24 months
- Must have an appointment during the study period
- Woman has not yet initiated breast cancer screening (no prior mammogram)
- No history of breast cancer
Who cannot join
- Prior diagnosis of breast cancer
- Major comorbidity that substantially affects their 10 year mortality
- Non-English speaker
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Edward S. Cooper Internal Medicine
Philadelphia, Pennsylvania, 19104
Family Medicine St. Leonard's Court
Philadelphia, Pennsylvania, 19104
Family Medicine
Philadelphia, Pennsylvania, 19104
Helen O. Dickens Center for Women's Health
Philadelphia, Pennsylvania, 19104
Penn Center for Primary Care
Philadelphia, Pennsylvania, 19104
Penn Internal Medicine Associates
Philadelphia, Pennsylvania, 19104
Penn OB/GYN Associates
Philadelphia, Pennsylvania, 19104
Internal Medicine Radnor
Radnor, Pennsylvania, 19087
Penn Health for Women
Radnor, Pennsylvania, 19087
About this study
Official title: PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool
In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool will be pilot tested, and then implemented and tested in nine primary care and OB/GYN practices within the University of Pennsylvania Health System.
Read the detailed description
In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool incorporates questions about a women's personal history of breast cancer and compares her to the average women her age in terms of breast cancer risk. The tool helps the women to understand the benefits and risks of breast cancer screening. This tool will be pilot tested using SSI to help develop the final version of the decision aid tool. The decision aid tool will then be implemented and tested in nine general internal medicine, family medicine, and OB/GYN practices within the University of Pennsylvania Health System.
- Conditions
- Breast Cancer
- Being tested
- Breast Cancer Screening 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.
Breast Cancer Screening Decision AidBehavioural
The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid. Receives: Behavioral: Breast Cancer Screening Decision Aid |
| Standard of Care | No intervention | Those in the standard of care arm will not be given access to the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography Use Correlated to Personal Risk of Breast Cancer
Medical charts of women in both the intervention and control groups of the study will be analyzed to determine if these women initiated breast cancer screening (mammography) correlated to their personal risk of breast cancer as displayed by the decision aid.
Measured: One year post-intervention
Secondary outcomes (1)
Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception
Six weeks after a women's appointment with their primary care or OB/GYN provider, they will receive a post-intervention survey which will assess knowledge, worry, satisfaction, numeracy, behavior, etc.
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2017
- Study completionNov 2017
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Schapira, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879189
- Sponsor's protocol ID
- 81670
- Status last verified
- Nov 2018
- First submitted
- 12 Jun 2013
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool
- ClinicalTrials.gov ID
- NCT01879189
- Acronym / sponsor ID
- 81670
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,302 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Jun 2013 (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.
In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool will be pilot tested, and then implemented and tested in nine primary care and OB/GYN practices within the University of Pennsylvania Health System.
Detailed description
In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool incorporates questions about a women's personal history of breast cancer and compares her to the average women her age in terms of breast cancer risk. The tool helps the women to understand the benefits and risks of breast cancer screening. This tool will be pilot tested using SSI to help develop the final version of the decision aid tool. The decision aid tool will then be implemented and tested in nine general internal medicine, family medicine, and OB/GYN practices within the University of Pennsylvania Health System.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Behavioral: Breast Cancer Screening Decision AidThose in the decision aid arm of the study will be given access to the breast cancer screening decision aid. |
| Standard of Care | No intervention | –Those in the standard of care arm will not be given access to the decision aid. |
Who may qualify
- Ages
- 39 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women ages 39-48
- Patient of one of the nine primary care or OB/GYN practices that are participating in the study
- Must have had an appointment at one of these locations in the past 24 months
- Must have an appointment during the study period
- Woman has not yet initiated breast cancer screening (no prior mammogram)
Key exclusion criteria (3 listed)
- Prior diagnosis of breast cancer
- Major comorbidity that substantially affects their 10 year mortality
- Non-English speaker
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 |
|---|---|---|
| Breast Cancer Screening Decision AidThe intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time. | Behavioural | Decision Aid |
Primary outcome
Mammography Use Correlated to Personal Risk of Breast Cancer
Time frame: One year post-intervention
Medical charts of women in both the intervention and control groups of the study will be analyzed to determine if these women initiated breast cancer screening (mammography) correlated to their personal risk of breast cancer as displayed by the decision aid.
1 secondary outcome
Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception
Time frame: 6 weeks post-intervention
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 29 Nov 2018.
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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.
Marilyn Schapira, MD principal investigator
University of Pennsylvania
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Screening Decision Aid in people with Breast Cancer, run by University of Pennsylvania at 9 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 6 inclusion and 3 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Mammography Use Correlated to Personal Risk of Breast Cancer (time frame: One year post-intervention). 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 29 Nov 2018.