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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

255

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach

2 countries

326 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

First Submitted

Initial submission to the registry

May 21, 2019

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5.7 years

First QC Date

May 21, 2019

Last Update Submit

July 14, 2025

Conditions

Prostate Adenocarcinoma Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer

Keywords

ProstateAdenocarcinoma

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

Trajectory of change in work ability at 3 months measured by Global Work Ability
Baseline up to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by Global Work Ability
Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by Work Limitations Questionnaire (WLQ)
From baseline to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by Work Limitations Questionnaire (WLQ)
Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by employment status
Baseline up to 3 months after treatment completion
+3 more secondary outcomes

Other Outcomes (1)

Effect of race and income on treatment-related function, work environment, and type of treatment
Up to 6 months after treatment completion

Study Arms (4)

Race: Non-Hispanic African American

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: InterviewOther: Questionnaire Administration

Race: Non-Hispanic White

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: InterviewOther: Questionnaire Administration

Income: Lower Income

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: InterviewOther: Questionnaire Administration

Income: Higher Income

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: InterviewOther: Questionnaire Administration

Interventions

InterviewOTHER

Undergo interview

Income: Higher IncomeIncome: Lower IncomeRace: Non-Hispanic African AmericanRace: Non-Hispanic White

Questionnaire AdministrationOTHER

Ancillary studies

Income: Higher IncomeIncome: Lower IncomeRace: Non-Hispanic African AmericanRace: Non-Hispanic White

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Diagnosed with adenocarcinoma of the prostate, stage I, II, or III and scheduled to undergo prostatectomy or initiate radiation

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Wake Forest University Health Scienceslead
National Cancer Institute (NCI)collaborator

Study Sites (326)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, 71913, United States

Location

Kaiser Permanente-Anaheim

Anaheim, California, 92806, United States

Location

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, 93420, United States

Location

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Kaiser Permanente-Fontana

Fontana, California, 92335, United States

Location

Kaiser Permanente-Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034, United States

Location

Kaiser Permanente-Ontario

Ontario, California, 91761, United States

Location

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, 93444, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

Location

Saint Francis Cancer Center

Colorado Springs, Colorado, 80923, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Mercy Medical Center

Durango, Colorado, 81301, United States

Location

Southwest Oncology PC

Durango, Colorado, 81301, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, 80501, United States

Location

Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

Beebe South Coastal Health Campus

Frankford, Delaware, 19945, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Island Urology-Hilo

Hilo, Hawaii, 96720, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza