Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer

Recurrent Prostate Carcinoma Clinical Trial

Official title:

Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122743
• Other study ID #: IRB00041151
• Secondary ID: NCI-2016-01590CC
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hormone-Resistant Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Carcinoma
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

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