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


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

Intervention:

  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Purpose: 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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03122743

Sponsor: Wake Forest University Health Sciences

Primary Outcome Measures:

  • Measure: Change in distress score, assessed by the Distress Thermometer
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in serum cortisol levels
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in serum epinephrine levels
  • Time Frame: Up to 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Change in levels of distress assessed by the Distress Thermometer
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in serum cortisol levels
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in serum epinephrine levels
  • Time Frame: Baseline up to 1 year
  • Safety Issue:

Estimated Enrollment: 60

Study Start Date: February 20, 2017

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Location:

  • Comprehensive Cancer Center of Wake Forest University
  • Winston-Salem North Carolina 27157 United States

View trial on ClinicalTrials.gov


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