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

Completed

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

• Registration Number: NCT03122743
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study First Submitted: 2016-10-27
• Study Start: 2017-02-22
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-21
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-24
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (collection of samples, questionnaires)	Biospecimen Collection	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.
Ancillary-Correlative (collection of samples, questionnaires)	Questionnaire Administration	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.
Ancillary-Correlative (collection of samples, questionnaires)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States