Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer
Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
4 other identifiers
observational
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2020
CompletedMarch 10, 2022
March 1, 2022
3.6 years
October 27, 2016
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change in distress score, assessed by the Distress Thermometer
Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer
Up to 1 year
Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress
Up to 1 year
Change in serum cortisol levels
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
Up to 1 year
Change in serum epinephrine levels
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
Up to 1 year
Secondary Outcomes (4)
Change in levels of distress assessed by the Distress Thermometer
Baseline up to 1 year
Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
Baseline up to 1 year
Change in serum cortisol levels
Baseline up to 1 year
Change in serum epinephrine levels
Baseline up to 1 year
Other Outcomes (3)
Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Baseline up to 1 year
Change in serum cortisol AUC values
Baseline up to 1 year
Change in serum epinephrine area under the curve (AUC) values
Baseline up to 1 year
Study Arms (1)
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.
Interventions
Undergo collection of serum samples
Correlative studies
Ancillary studies
Eligibility Criteria
Adult men with prostate cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart Frizzell
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
April 21, 2017
Study Start
February 22, 2017
Primary Completion
September 24, 2020
Study Completion
September 24, 2020
Last Updated
March 10, 2022
Record last verified: 2022-03