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

Wake Forest University (WFU)

Status: Completed

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

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03122743

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 85316 (Other Identifier)

IRB00041151

NCI-2016-01590 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

61 participants in 1 patient group

Ancillary-Correlative (collection of samples, questionnaires)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration