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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Prostate Carcinoma; Stage I Prostate Cancer; Stage II Prostate Cancer; Hormone-Resistant Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Biospecimen Collection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Adult men with prostate cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (collection of samples, questionnaires); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of serum samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bart Frizzell, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): September 24, 2020
• Study Completion (Actual): September 24, 2020

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRB00041151; P30CA012197 (U.S. NIH Grant/Contract); NCI-2016-01590 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 85316 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No