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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05102500
Other study ID # 21-3100.cc
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 14, 2021
Est. completion date June 2024

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 236
Est. completion date June 2024
Est. primary completion date December 2, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient opinions on decision making process through semi-structure interviews 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
Primary 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 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
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