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

Completed

• Conditions: Stage III Prostate Cancer; Stage II Prostate Cancer; Prostate Adenocarcinoma; Stage I Prostate Cancer

• Registration Number: NCT03963739
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-28
• Study Start: 2019-07-19
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 255

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in work ability measured by Global Work Ability	Baseline up to 6 months after treatment completion	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.

Secondary Outcome Measures

Name	Time	Method
Trajectory of change in work ability at 3 months measured by Global Work Ability	Baseline up to 3 months after treatment completion	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.
Trajectory of change in work ability at 6 months measured by Global Work Ability	Baseline up to 6 months after treatment completion	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.
Trajectory of change in work ability at 6 months measured by Work Limitations Questionnaire (WLQ)	Baseline up to 6 months after treatment completion	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.
Trajectory of change in work ability at 6 months measured by employment status	Baseline up to 6 months after treatment completion	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.
Difference between preferred and actual length of leave	Up to 6 months after treatment completion	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.
Trajectory of change in work ability at 3 months measured by Work Limitations Questionnaire (WLQ)	From baseline to 3 months after treatment completion	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.
Trajectory of change in work ability at 3 months measured by employment status	Baseline up to 3 months after treatment completion	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.

Trial Locations

Locations (324)

Cancer Center at Saint Joseph's; 🇺🇸 Phoenix, Arizona, United States

Mercy Hospital Fort Smith; 🇺🇸 Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs; 🇺🇸 Hot Springs, Arkansas, United States

Kaiser Permanente-Anaheim; 🇺🇸 Anaheim, California, United States

Mission Hope Medical Oncology - Arroyo Grande; 🇺🇸 Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park; 🇺🇸 Baldwin Park, California, United States

Kaiser Permanente-Bellflower; 🇺🇸 Bellflower, California, United States

Kaiser Permanente-Fontana; 🇺🇸 Fontana, California, United States

Kaiser Permanente-Irvine; 🇺🇸 Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

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