Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of serum samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of distress assessed by the Distress Thermometer | Will fit a two-way random effects model to examine the time course of distress levels. | Baseline up to 1 year |
| Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) | 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. | Baseline up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult men with prostate cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bart Frizzell | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2020 | Nov 20, 2020 |
Not provided
Not provided
Not provided
Not provided
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
Will fit a two-way random effects model to examine the time course of stress levels. |
| Baseline up to 1 year |
| Change in serum cortisol levels | Will fit a two-way random effects model to examine the time course of serum cortisol levels. | Baseline up to 1 year |
| Change in serum epinephrine levels | Will fit a two-way random effects model to examine the time course of serum epinephrine levels. | Baseline up to 1 year |
| Change in serum cortisol AUC values | 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. | Baseline up to 1 year |
| Change in serum epinephrine area under the curve (AUC) values | 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. | Baseline up to 1 year |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided