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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hormone-Resistant Prostate Cancer, Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (collection of samples, questionnaires)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of serum samples<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |