Breast CancerNCT05064098
Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients
An observational study of Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. 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
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 1 Jun 2026
- Phase
- Observational
- 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
Study population: Pre-surgical breast cancer patients and breast cancer survivors
Who may be able to join
- Pre-surgical female breast cancer patients
- Female breast cancer survivors
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hopspital
Aurora, Colorado, 80045
About this study
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.
Read the detailed description
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Surgical Breast Cancer Patients | Adult female patients newly diagnosed with stage 0-III breast cancer seen as a surgical consultation from 06/01/2019 to present. | |
| Breast Cancer Survivors | Breast Cancer Survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted patient reported outcomes up to 1 year after
Predicted patient reported outcomes for each domain six-months and 1 year after breast surgery.
Measured: 12 months
Actual patient reported outcomes for each domain after surgery
Actual PRO scores for each domain six-months after surgery
Measured: 6 month
Compare predicted and actual outcomes
Comparison of predicted versus actual PRO scores in patients undergoing surgery
Measured: 12 months
Patients preferred method of communicating results
Patients' preferred means of receiving and communicating PRO results.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start29 Jun 2021
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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 Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Tevis, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064098
- Sponsor's protocol ID
- 21-3576.cc
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05064098
- Acronym / sponsor ID
- 21-3576.cc
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 1 Oct 2021 (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 study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.
Detailed description
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgical Breast Cancer Patients | – | –Adult female patients newly diagnosed with stage 0-III breast cancer seen as a surgical consultation from 06/01/2019 to present. |
| Breast Cancer Survivors | – | –Breast Cancer Survivors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-surgical breast cancer patients and breast cancer survivors
Key inclusion criteria (2 listed)
- Pre-surgical female breast cancer patients
- Female breast cancer survivors
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predicted patient reported outcomes up to 1 year after
Time frame: 12 months
Predicted patient reported outcomes for each domain six-months and 1 year after breast surgery.
Actual patient reported outcomes for each domain after surgery
Time frame: 6 month
Actual PRO scores for each domain six-months after surgery
Compare predicted and actual outcomes
Time frame: 12 months
Comparison of predicted versus actual PRO scores in patients undergoing surgery
Patients preferred method of communicating results
Time frame: 12 months
Patients' preferred means of receiving and communicating PRO results.
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 Jul 2026.
- 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.
Sarah Tevis principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Colorado, Denver 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 2 inclusion and 0 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 Jul 2026. 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?
Predicted patient reported outcomes up to 1 year after (time frame: 12 months). 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 10 Jul 2026.