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2021-05-14
2021-12-02
2024-05-10
236
NCT05102500
University of Colorado, Denver
University of Colorado, Denver
OBSERVATIONAL
Second Opinions in Oncology
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-10-19 | N/A | 2024-07-25 |
2021-10-19 | N/A | 2024-07-26 |
2021-11-01 | N/A | 2024-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Second opinion retention rates for cancer patients at University of Colorado | 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 | Measure Description | Time Frame |
|---|---|---|
| Univariate statistical analysis affecting second opinion retention rates | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
