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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03122743
Other study ID # IRB00041151
Secondary ID NCI-2016-01590CC
Status Completed
Phase
First received
Last updated
Start date February 22, 2017
Est. completion date September 24, 2020

Study information

Verified date March 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.


Description:

PRIMARY OBJECTIVES: I. To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with perceived stress or distress over time in two to five consecutive visits. SECONDARY OBJECTIVES: I. To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits. II. To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits. III. To determine the change in levels of stress in men with prostate cancer over time in two to five consecutive visits IV. To determine the change in levels of distress in men with prostate cancer over time in two to five consecutive visits. TERTIARY OBJECTIVES: I. To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with prostate cancer progression two to five visits. OUTLINE: Patients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 24, 2020
Est. primary completion date September 24, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - A confirmed diagnosis of prostate cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 - Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: - History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators

Study Design


Intervention

Procedure:
Biospecimen Collection
Undergo collection of serum samples
Other:
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) Will determine whether there are any differences at each of the time points in serum epinephrine or cortisol levels using one-way analysis of variance (ANOVA) models. Baseline up to 1 year
Other Change in serum cortisol AUC values Will be compared across the 4-levels of progression (CR, PR, SD, and PD) or 2-levels of progression (CR/PR vs SD/PD) using ANOVA models. These models can be run separately for each of the 3 groups of patients - and also in an overall model with all patients included and a covariate for group and group by AUC value interaction. Baseline up to 1 year
Other Change in serum epinephrine area under the curve (AUC) values Will be compared across the 4-levels of progression (CR, PR, SD, and PD) or 2-levels of progression (CR/PR vs SD/PD) using ANOVA models. These models can be run separately for each of the 3 groups of patients - and also in an overall model with all patients included and a covariate for group and group by AUC value interaction. Baseline up to 1 year
Primary Change in distress score, assessed by the Distress Thermometer Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer Up to 1 year
Primary Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress Up to 1 year
Primary Change in serum cortisol levels Will calculate the change in serum cortisol levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int Up to 1 year
Primary Change in serum epinephrine levels Will calculate the change in serum epinephrine levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int Up to 1 year
Secondary Change in levels of distress assessed by the Distress Thermometer Will fit a two-way random effects model to examine the time course of distress levels. Baseline up to 1 year
Secondary Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire Will fit a two-way random effects model to examine the time course of stress levels. Baseline up to 1 year
Secondary Change in serum cortisol levels Will fit a two-way random effects model to examine the time course of serum cortisol levels. Baseline up to 1 year
Secondary Change in serum epinephrine levels Will fit a two-way random effects model to examine the time course of serum epinephrine levels. Baseline up to 1 year
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