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

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ClinicalTrials.gov Identifier: NCT03122743
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hormone-Resistant Prostate Cancer Recurrent Prostate Carcinoma Stage I Prostate Cancer Stage II Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Ancillary-Correlative (collection of samples, questionnaires)
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.
Procedure: Biospecimen Collection
Undergo collection of serum samples

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult men with prostate cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122743


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rhonda L. Bitting    336-716-0327    rbitting@wakehealth.edu   
Principal Investigator: Rhonda L. Bitting         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rhonda Bitting Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03122743     History of Changes
Other Study ID Numbers: IRB00041151
NCI-2016-01590 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 85316 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Stress, Psychological
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms