Effect of Treatment on Work Experience in Patients With Stage I-III Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)

Conditions
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Stage I Prostate Cancer, Stage II Prostate Cancer, Prostate Adenocarcinoma, Stage III Prostate Cancer

Intervention / Treatment
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* Other: Interview
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male diagnosed with adenocarcinoma of the prostate, stage I, II, or III. Patient may have already received hormonal therapy or expect to receive hormonal therapy as treatment for adenocarcinoma of the prostate Scheduled to undergo prostatectomy or initiate radiation for primary curative treatment of adenocarcinoma of the prostate within 90 days of enrollment Self-identify as African American/black, non-Hispanic OR white, non-Hispanic; Participants are considered African American for recruitment purposes if they (1) identify solely as African American for race OR (2) identify as African American and white for race, but do not identify as also being of another race. Participants are considered white for recruitment purposes if they select white and no other race. (These identities are based on participant self-report during the screening process.) Eastern Cooperative Oncology Group (ECOG) score = 0 or 1 Worked within the past 14 days prior to screening (no minimum number of hours required) OR (a) worked at some point between March 1, 2020 - March 14, 2020 and (b) subsequently lost job involuntarily due to COVID-19. Intends to be working 6 months from screening (if opportunity to work is available pending the COVID-19 pandemic considerations) Patient is willing to provide answers on the patient eligibility questionnaire regarding household income Age at time of screening is > or = 18 Can speak and understand spoken English Ability to understand an informed consent document (even if only verbally) and willingness to agree to informed consent document Access to telephone or willingness to travel to National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site for each of the three interviewer-administered structured questionnaires Able to hear sufficiently to understand a conversation determined by a simple test given at screening Has not previously had a prostatectomy, radiation therapy, or chemotherapy to treat adenocarcinoma of the prostate Not expected (at time of screening) to receive chemotherapy for primary treatment of adenocarcinoma of the prostate Exclusion Criteria: Patient has received therapy for any other cancer within last 3 years (except for non-melanoma skin cancer) Patient plans to receive therapy for any other cancer within the next year (except for non-melanoma skin cancer)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Race: Non-Hispanic African American<br>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<br>* Undergo interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Race: Non-Hispanic White<br>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<br>* Undergo interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Income: Lower Income<br>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<br>* Undergo interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Income: Higher Income<br>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<br>* Undergo interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to 6 months after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 6 months after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Adenocarcinoma