An observational study in Prostate Adenocarcinoma, Stage I Prostate Cancer and Stage II Prostate Cancer, sponsored by Wake Forest University Health Sciences. Completed at 326 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Wake Forest University Health Sciences · Observational
The objective of this study is to examine how adenocarcinoma of the prostate treatment differentially affects African American men's ability to work and to describe and compare changes in work ability (as measured through self-reported global work ability item) reported by African American and white adenocarcinoma of the prostate survivors before treatment and 6 months after treatment completion.
This observational, longitudinal study will recruit approximately 255 patients through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). The recruitment goal will be to have 160 participants who complete the interviewer-administered Structured Questionnaire at all three time points. All participants will be administered the first Structured Questionnaire prior to a prostatectomy or initiation of radiation therapy to treat adenocarcinoma of the prostate. Participants will also be administered Structured Questionnaires at three and six months after the prostatectomy or completion of radiation therapy. For most patients, the time between study enrollment and completion of participation will be approximately 6 - 10 months. Interviewer-administered Structured Questionnaires will address work ability, job characteristics, presence of symptoms associated with adenocarcinoma of the prostate treatment, and general background information.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 255 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosed with adenocarcinoma of the prostate, stage I, II, or III and scheduled to undergo prostatectomy or initiate radiation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo an interview over 40-60 minutes at baseline and 3 and 6 months after treatment to describe and compare changes in ability to work and employment status/income.
Other: Interview · Other: Questionnaire Administration
Patients undergo an interview over 40-60 minutes at baseline and 3 and 6 months after treatment to describe and compare changes in ability to work and employment status/income.
Other: Interview · Other: Questionnaire Administration
Patients undergo an interview over 40-60 minutes at baseline and 3 and 6 months after treatment to describe and compare changes in ability to work and employment status/income.
Other: Interview · Other: Questionnaire Administration
Patients undergo an interview over 40-60 minutes at baseline and 3 and 6 months after treatment to describe and compare changes in ability to work and employment status/income.
Other: Interview · Other: Questionnaire Administration
Undergo interview
Ancillary studies
Change in work ability measured by Global Work Ability
Calculate 95% confidence intervals around the work ability score and the change in the work ability score. A two group t-test will be used to compare changes in the work ability score by race (white, African American), followed by a general linear model to compare changes in work ability with adjustment for demographic, work environment, and other baseline characteristics.
Time frame: Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by Global Work Ability
Measured by Global Work Ability. Quantify this change using means and 95% confidence intervals. In mixed models to account for the repeated measures over time, will model this change by race, income, and the interaction between race and income. Will also test for race by time and income by time interactions to compare the trajectories of change over time.
Time frame: Baseline up to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by Global Work Ability
In mixed models to account for the repeated measures over time, will model this change by race, income, and the interaction between race and income. Will also test for race by time and income by time interactions to compare the trajectories of change over time.
Time frame: Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by Work Limitations Questionnaire (WLQ)
Quantify this change using means and 95% confidence intervals. In mixed models to account for the repeated measures over time, will model this change by race, income, and the interaction between race and income. Will also test for race by time and income by time interactions to compare the trajectories of change over time.
Time frame: From baseline to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by Work Limitations Questionnaire (WLQ)
Quantify this change using means and 95% confidence intervals. In mixed models to account for the repeated measures over time, will model this change by race, income, and the interaction between race and income. Will also test for race by time and income by time interactions to compare the trajectories of change over time.
Time frame: Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by employment status
A random effects logistic regression model (if binary) or multinomial model (if more than 2 categories) for modeling employment status. Backwards model selection and Akaike information criterion (AIC) criteria will be utilized to identify the best model fit.
Time frame: Baseline up to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by employment status
A random effects logistic regression model (if binary) or multinomial model (if more than 2 categories) for modeling employment status. Backwards model selection and AIC criteria will be utilized to identify the best model fit.
Time frame: Baseline up to 6 months after treatment completion
Difference between preferred and actual length of leave
Examine whether demographics, treatment, psychosocial and physical effects of treatment, and work environment factors impact (a) desired and (b) actual length of leave following treatment for adenocarcinoma of the prostate. Factors that are significant at an alpha level of 0.25 or less or have significant interactions will be entered into a general linear model.
Time frame: Up to 3 months after treatment completion
Difference between preferred and actual length of leave
Examine whether demographics, treatment, psychosocial and physical effects of treatment, and work environment factors impact (a) desired and (b) actual length of leave following treatment for adenocarcinoma of the prostate. Factors that are significant at an alpha level of 0.25 or less or have significant interactions will be entered into a general linear model.
Time frame: Up to 6 months after treatment completion
Effect of race and income on treatment-related function, work environment, and type of treatment
Will use interactions to test moderation effects of race and income on the relationship between adenocarcinoma of the prostate treatment-related function (bladder, bowel, and hormonal function), work environment (e.g., work demands, workplace control, and social support), and type of treatment (surgery or radiation therapy, hormonal treatment) regarding outcomes of work limitations (as measured by the Work Limitations Questionnaire), Global Work Ability item, employment status, and preferred and actual length. Work ability, as measured through the WLQ and the Global Work Ability measures, and preferred versus actual length of time off work will be modeled as continuous variables in general linear models; employment status will be modeled as dichotomous (logistic regression) or in a multinomial model depending on the distribution of responses.
Time frame: Up to 6 months after treatment completion
Showing the first 100 of 326 sites across 2 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Time frame: 6 months after publication for a 2 year duration
Access criteria: upon request to NCORP@wakehealth.edu
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Mar 2025, 68 months.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's 68 months is close to that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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