Breast CancerNCT03116035
Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
A study testing Web-based decision aid and Standard websites in people with Breast Cancer and Knowledge, Attitudes, Practice, run by University of Wisconsin, Madison.
Trial summary
This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Knowledge, Attitudes, Practice
- What is being tested?
- Web-based decision aid and Standard websites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2014to 28 Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
- >18 years of age
- Newly diagnosed stage 0-3 breast cancer
- English speaking
- Has an email address
- No prior recent contact with the breast surgeon
About this study
Official title: A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.
- Conditions
- Breast Cancer, Knowledge, Attitudes, Practice
- Being tested
- Web-based decision aid, Standard websites
- Medical subject headings
- Breast Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based decision aidOther
Patients were randomized to receive links to a commercially available decision aid.
Standard websitesOther
Patients were randomized to receive links to standard, high-quality websites.
| Study group | Role | What they receive |
|---|---|---|
| Web-based decision aid | Active comparator | A commercially available web-based breast cancer surgery decision aid Receives: Other: Web-based decision aid |
| Standard websites | Active comparator | selected, high-quality standard web-sites Receives: Other: Standard websites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge using the Breast Cancer Decision Quality Instrument
Measured: immediately prior to the surgical consultation
Secondary outcomes (3)
Decisional concordance using the Breast Cancer Decision Quality Instrument
Measured: immediately prior to the surgical consultation
Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
Measured: following the surgical consultation but prior to the surgery
Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey
Measured: at completion of patient accrual, estimated to be 2 years after initiating study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start24 Apr 2014
- Primary completion28 Jun 2016
- Study completion28 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116035
- Sponsor's protocol ID
- 2013-1500
- Other IDs
- UW13089
- Status last verified
- Jan 2021
- First submitted
- 3 Apr 2017
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12.
PubMed 29246705
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
- ClinicalTrials.gov ID
- NCT03116035
- Acronym / sponsor ID
- 2013-1500
- Conditions
- Breast Cancer, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 24 Apr 2014 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 28 Jun 2016 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based decision aid | Active comparator | Other: Web-based decision aidA commercially available web-based breast cancer surgery decision aid |
| Standard websites | Active comparator | Other: Standard websitesselected, high-quality standard web-sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Web-based decision aidPatients were randomized to receive links to a commercially available decision aid. | Other | Web-based decision aid |
| Standard websitesPatients were randomized to receive links to standard, high-quality websites. | Other | Standard websites |
Primary outcome
Knowledge using the Breast Cancer Decision Quality Instrument
Time frame: immediately prior to the surgical consultation
3 secondary outcomes
Decisional concordance using the Breast Cancer Decision Quality Instrument
Time frame: immediately prior to the surgical consultation
Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
Time frame: following the surgical consultation but prior to the surgery
Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey
Time frame: at completion of patient accrual, estimated to be 2 years after initiating study
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 12 Jun 2023.
- Derived from this study: PubMed 29246705Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based decision aid and Standard websites in people with Breast Cancer and Knowledge, Attitudes, Practice, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge using the Breast Cancer Decision Quality Instrument (time frame: immediately prior to the surgical consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116035, which also lists 1 linked publication.
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 12 Jun 2023.