Breast CancerNCT05102500
Second Opinions in Oncology
An observational study of Breast Cancer and Pancreatic Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 10 May 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients who are 18 years of age or older who received a second opinion at the University of Colorado will be included in the retrospective chart review and analysis. A subset of these patients will be invited to participate in semi-structured interviews
Who may be able to join
- Cancer patients who are 18 years of age or older who received a second opinion at the University of Colorado.
- A subset of these patients will be invited to participate in semi-structured interviews
Who cannot join
- Patients under the age of 18.
- Patients who did not receive a second opinion at the University of Colorado.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Examining the Decision-Making Process and Characteristics of Cancer Patients Who Sought Second Opinions at the University of Colorado
The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion.
Read the detailed description
The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion. To do this, the PI will examine the second opinion retention rates and patient characteristics of three distinct populations: breast cancer patients, pancreatic cancer patients and colorectal cancer patients. The study team hypothesize the majority of breast cancer and colorectal cancer patients who seek a second opinion at the University of Colorado, will preferentially choose to return to their first provider, whereas patients with pancreatic cancer who seek a second opinion at the sponsor's institution will be more likely to go on to receive care at the University of Colorado. The PI predicts the difference in second opinion retention rates between these three populations is due to the ability of the second opinion pancreatic cancer provider's ability to offer more treatment or a different treatment plan at the sponsor institution relative to the patient's first provider. The study team also predict that socioeconomic status and education will have a positive correlation with changing to with a second opinion physician whereas geographic distance and treatment plan similarity will have a negative correlation. The study team will assess this hypothesis by conducting a retrospective cohort study of breast, pancreatic, and colorectal cancer patients who received a second opinion at the University of Colorado. From this cohort, the study team will identify patients who both received their care at the sponsor institution and patients who returned to their initial provider to receive care. The study team will invite these patients to participate in semi-structured interviews to better understand how and why the patient made their treatment decisions.
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Colorectal 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 |
|---|---|---|
| Retrospective Chart Review Patients | The PI will conduct a retrospective chart review of breast cancer, colorectal cancer, and pancreatic cancer patients to better understand the patient, disease, and treatment characteristics that play a role in second opinion retention rates. | |
| Semi-structure Interview Patients | The PI will conduct semi-structured interviews with breast cancer, colorectal cancer and pancreatic cancer patients to better understand the decision-making process that goes into continued care with their primary or second opinion physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second opinion retention rates for cancer patients at University of Colorado
- The study team will perform a retrospective chart review to identify patients with breast cancer, colorectal cancer or pancreatic cancer who were seen by a surgeon at the University of Colorado for a second opinion and to examine whether or not the subject stayed at the Cancer Center to receive cancer care. The study team predict the second opinion retention rate - the percent of patients who received a second opinion at the Cancer Center and ultimately received care at this institution - will be significantly higher for pancreatic cancer patients than for breast and colorectal cancer patients.
Measured: 12 months
Secondary outcomes (1)
Univariate statistical analysis affecting second opinion retention rates
- The study team will perform univariate analysis on patient, disease, and treatment characteristics for the second opinion patients who did and did not receive cancer care at this institution to identify factors associated with high and low second opinion retention rates. The study team hypothesize patient factors (socioeconomic status, education, and geographic distance), disease factors (more advanced disease or less common tumor subtypes), and treatment factors (offering more or different treatment) will affect the second opinion retention rates for breast and pancreatic cancer patients.
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 Nov 2021
- Study start14 May 2021
- Primary completion2 Dec 2021
- Study completion10 May 2024
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
- 236 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, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102500
- Sponsor's protocol ID
- 21-3100.cc
- Status last verified
- Feb 2026
- First submitted
- 19 Oct 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Decision-Making Process and Characteristics of Cancer Patients Who Sought Second Opinions at the University of Colorado
- ClinicalTrials.gov ID
- NCT05102500
- Acronym / sponsor ID
- 21-3100.cc
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 1 Nov 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.
The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion.
Detailed description
The long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion. To do this, the PI will examine the second opinion retention rates and patient characteristics of three distinct populations: breast cancer patients, pancreatic cancer patients and colorectal cancer patients. The study team hypothesize the majority of breast cancer and colorectal cancer patients who seek a second opinion at the University of Colorado, will preferentially choose to return to their first provider, whereas patients with pancreatic cancer who seek a second opinion at the sponsor's institution will be more likely to go on to receive care at the University of Colorado. The PI predicts the difference in second opinion retention rates between these three populations is due to the ability of the second opinion pancreatic cancer provider's ability to offer more treatment or a different treatment plan at the sponsor institution relative to the patient's first provider. The study team also predict that socioeconomic status and education will have a positive correlation with changing to with a second opinion physician whereas geographic distance and treatment plan similarity will have a negative correlation. The study team will assess this hypothesis by conducting a retrospective cohort study of breast, pancreatic, and colorectal cancer patients who received a second opinion at the University of Colorado. From this cohort, the study team will identify patients who both received their care at the sponsor institution and patients who returned to their initial provider to receive care. The study team will invite these patients to participate in semi-structured interviews to better understand how and why the patient made their treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Chart Review Patients | – | –The PI will conduct a retrospective chart review of breast cancer, colorectal cancer, and pancreatic cancer patients to better understand the patient, disease, and treatment characteristics that play a role in second opinion retention rates. |
| Semi-structure Interview Patients | – | –The PI will conduct semi-structured interviews with breast cancer, colorectal cancer and pancreatic cancer patients to better understand the decision-making process that goes into continued care with their primary or second opinion physician. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients who are 18 years of age or older who received a second opinion at the University of Colorado will be included in the retrospective chart review and analysis. A subset of these patients will be invited to participate in semi-structured interviews
Key inclusion criteria (2 listed)
- Cancer patients who are 18 years of age or older who received a second opinion at the University of Colorado.
- A subset of these patients will be invited to participate in semi-structured interviews
Key exclusion criteria (2 listed)
- Patients under the age of 18.
- Patients who did not receive a second opinion at the University of Colorado.
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
Second opinion retention rates for cancer patients at University of Colorado
Time frame: 12 months
a. The study team will perform a retrospective chart review to identify patients with breast cancer, colorectal cancer or pancreatic cancer who were seen by a surgeon at the University of Colorado for a second opinion and to examine whether or not the subject stayed at the Cancer Center to receive cancer care. The study team predict the second opinion retention rate - the percent of patients who received a second opinion at the Cancer Center and ultimately received care at this institution - will be significantly higher for pancreatic cancer patients than for breast and colorectal cancer patients.
1 secondary outcome
Univariate statistical analysis affecting second opinion retention rates
Time frame: 12 months
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 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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
Colorado Research Center
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 and Pancreatic 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 2 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 3 Feb 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?
Second opinion retention rates for cancer patients at University of Colorado (time frame: 12 months). 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 3 Feb 2026.