Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits.
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To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits.
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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:
- 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 Design
Arms and Interventions
| Arm | 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. |
Procedure: Biospecimen Collection
Undergo collection of serum samples
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Change in distress score, assessed by the Distress Thermometer [Up to 1 year]
Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer
- Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire [Up to 1 year]
Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress
- Change in serum cortisol levels [Up to 1 year]
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
- Change in serum epinephrine levels [Up to 1 year]
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
Secondary Outcome Measures
- Change in levels of distress assessed by the Distress Thermometer [Baseline up to 1 year]
Will fit a two-way random effects model to examine the time course of distress levels.
- Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire [Baseline up to 1 year]
Will fit a two-way random effects model to examine the time course of stress levels.
- Change in serum cortisol levels [Baseline up to 1 year]
Will fit a two-way random effects model to examine the time course of serum cortisol levels.
- Change in serum epinephrine levels [Baseline up to 1 year]
Will fit a two-way random effects model to examine the time course of serum epinephrine levels.
Other Outcome Measures
- Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) [Baseline up to 1 year]
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.
- Change in serum cortisol AUC values [Baseline up to 1 year]
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.
- Change in serum epinephrine area under the curve (AUC) values [Baseline up to 1 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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A confirmed diagnosis of prostate cancer
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Bart Frizzell, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00041151
- NCI-2016-01590
- CCCWFU 85316
- P30CA012197