- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05102500
Second Opinions in Oncology
February 2, 2026 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
236
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under the age of 18.
- Patients who did not receive a second opinion at the University of Colorado.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Univariate statistical analysis affecting second opinion retention rates
Time Frame: 12 months
|
a.
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.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient opinions on decision making process through semi-structure interviews
Time Frame: 12 months
|
a.
The study team will identify patients who both received their care at the second opinion institution and patients who returned to the initial provider to receive care.
The study team will invite these patients to participate in semi-structured interviews to better understand how and why treatment decisions were made.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Tevis, Colorado Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2021
Primary Completion (Actual)
December 2, 2021
Study Completion (Actual)
May 10, 2024
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Colorectal Neoplasms
- Breast Neoplasms
- Pancreatic Neoplasms
Other Study ID Numbers
- 21-3100.cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of Colorado, DenverCompletedStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerCanada
-
Mayo ClinicMarker Therapeutics, Inc.CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Central FloridaFlorida Department of HealthRecruitingBreast Cancer | Breast Cancer Female | Breast Cancer Diagnosis | Breast Cancer Survivors | Breast Cancer Detection | Breast Cancer AwarenessUnited States