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NCT Number: NCT03122743

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

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.

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Key information

Conditions

Hormone-Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Carcinoma Stage I Prostate Cancer Stage II Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of serum samples

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in distress score, assessed by the Distress Thermometer

    Time frame: Up to 1 year

    Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer

  2. Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire

    Time frame: 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

  3. Change in serum cortisol levels

    Time frame: 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

  4. Change in serum epinephrine levels

    Time frame: 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 outcomes

  1. Change in levels of distress assessed by the Distress Thermometer

    Time frame: Baseline up to 1 year

    Will fit a two-way random effects model to examine the time course of distress levels.

  2. Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire

    Time frame: Baseline up to 1 year

    Will fit a two-way random effects model to examine the time course of stress levels.

  3. Change in serum cortisol levels

    Time frame: Baseline up to 1 year

    Will fit a two-way random effects model to examine the time course of serum cortisol levels.

  4. Change in serum epinephrine levels

    Time frame: Baseline up to 1 year

    Will fit a two-way random effects model to examine the time course of serum epinephrine levels.

Other outcomes

  1. Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)

    Time frame: 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.

  2. Change in serum cortisol AUC values

    Time frame: 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.

  3. Change in serum epinephrine area under the curve (AUC) values

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2017
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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