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Effect of Treatment on Work E...

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

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-19

Study Completion Date

2025-03-25

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.

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Interview

Intervention Type OTHER

Undergo interview

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Interview

Intervention Type OTHER

Undergo interview

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Interview

Intervention Type OTHER

Undergo interview

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Interview

Intervention Type OTHER

Undergo interview

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Interview

Undergo interview

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Lesser, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Site Status

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status

Kaiser Permanente-Fontana

Fontana, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Site Status

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Mercy Medical Center

Durango, Colorado, United States

Site Status

Southwest Oncology PC

Durango, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status

Parker Adventist Hospital

Parker, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status

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

Savannah, Georgia, United States

Site Status