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



Status:Recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Cancer, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:February 20, 2017
End Date:August 2019

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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.

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.

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
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: Rhonda L. Bitting
Phone: 336-716-0327
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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mi
from
Winston-Salem, NC
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