Prostate AdenocarcinomaPCWNCT03963739
Effect of Treatment on Work Experience in Patients With Stage I-III Prostate Cancer
An observational study of Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Wake Forest University Health Sciences at 326 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer
- What is being tested?
- Interview and Questionnaire Administration
- How many people
- 255 participants
- Where
- 326 sitesin 2 countries
- Study dates
- 19 Jul 2019to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with adenocarcinoma of the prostate, stage I, II, or III and scheduled to undergo prostatectomy or initiate radiation
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Trial locations and contacts
326 sites in 2 countries.
301 sites in 2 countries
United States300 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Bronson Battle Creek
Battle Creek, Michigan, 49017
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Cox Cancer Center Branson
Branson, Missouri, 65616
Saint Michael Cancer Center
Bremerton, Washington, 98310
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
Highline Medical Center-Main Campus
Burien, Washington, 98166
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Cambridge Medical Center
Cambridge, Minnesota, 55008
Illinois CancerCare-Canton
Canton, Illinois, 61520
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Medical University of South Carolina
Charleston, South Carolina, 29425
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
Mercy Hospital
Coon Rapids, Minnesota, 55433
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Mary Bird Perkins Cancer Center - Covington
Covington, Louisiana, 70433
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Greater Regional Medical Center
Creston, Iowa, 50801
Carle on Vermilion
Danville, Illinois, 61832
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, 62526
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Porter Adventist Hospital
Denver, Colorado, 80210
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Dublin Methodist Hospital
Dublin, Ohio, 43016
Mercy Medical Center
Durango, Colorado, 81301
Southwest Oncology PC
Durango, Colorado, 81301
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Sanford South University Medical Center
Fargo, North Dakota, 58103
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Saint Francis Hospital
Federal Way, Washington, 98003
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Kaiser Permanente-Fontana
Fontana, California, 92335
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Beebe South Coastal Health Campus
Frankford, Delaware, 19945
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Unity Hospital
Fridley, Minnesota, 55432
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Wayne Hospital
Greenville, Ohio, 45331
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
Island Urology-Hilo
Hilo, Hawaii, 96720
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Island Urology
Honolulu, Hawaii, 96813
Queen's Cancer Center - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii, 96817
Kuakini Medical Center
Honolulu, Hawaii, 96817
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
Mary Bird Perkins Cancer Center - Houma
Houma, Louisiana, 70360
Terrebonne General Medical Center
Houma, Louisiana, 70360
Kaiser Permanente-Irvine
Irvine, California, 92618
Capital Region Southwest Campus
Jefferson City, Missouri, 65109
Castle Medical Center
Kailua, Hawaii, 96734
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Borgess Medical Center
Kalamazoo, Michigan, 49048
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Kettering Medical Center
Kettering, Ohio, 45429
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Saint Anthony Hospital
Lakewood, Colorado, 80228
Saint Clare Hospital
Lakewood, Washington, 98499
Fairfield Medical Center
Lancaster, Ohio, 43130
Beebe Medical Center
Lewes, Delaware, 19958
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Saint Rita's Medical Center
Lima, Ohio, 45801
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Littleton Adventist Hospital
Littleton, Colorado, 80122
Saint Joseph London
London, Kentucky, 40741
Longmont United Hospital
Longmont, Colorado, 80501
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034
Jewish Hospital
Louisville, Kentucky, 40202
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Marietta Memorial Hospital
Marietta, Ohio, 45750
OhioHealth Marion General Hospital
Marion, Ohio, 43302
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia, 23116
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Bon Secours Westchester Emergency Center
Midlothian, Virginia, 23113
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Health Partners Inc
Minneapolis, Minnesota, 55454
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Monticello Cancer Center
Monticello, Minnesota, 55362
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Knox Community Hospital
Mount Vernon, Ohio, 43050
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Westfields Hospital/Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
New Ulm Medical Center
New Ulm, Minnesota, 56073
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Licking Memorial Hospital
Newark, Ohio, 43055
Newark Radiation Oncology
Newark, Ohio, 43055
Lakeland Hospital Niles
Niles, Michigan, 49120
Bon Secours DePaul Medical Center
Norfolk, Virginia, 23505
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Creighton University Medical Center
Omaha, Nebraska, 68131
Kaiser Permanente-Ontario
Ontario, California, 91761
Ascension Borgess Cancer Center
Oshtemo, Michigan, 49008
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Midlands Community Hospital
Papillion, Nebraska, 68046
Parker Adventist Hospital
Parker, Colorado, 80138
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Illinois CancerCare-Peru
Peru, Illinois, 61354
Valley Radiation Oncology
Peru, Illinois, 61354
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
Bon Secours Maryview Medical Center
Portsmouth, Virginia, 23707
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Valley Medical Center
Renton, Washington, 98055
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Reid Health
Richmond, Indiana, 47374
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Nash General Hospital
Rocky Mount, North Carolina, 27804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165
North Grove Medical Park
Spartanburg, South Carolina, 29303
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina, 29307
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Memorial Medical Center
Springfield, Illinois, 62781
Springfield Memorial Hospital
Springfield, Illinois, 62781
Springfield Regional Cancer Center
Springfield, Ohio, 45504
Springfield Regional Medical Center
Springfield, Ohio, 45505
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109
Mercy Hospital South
St Louis, Missouri, 63128
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482
Lakeview Hospital
Stillwater, Minnesota, 55082
Bon Secours Health Center at Harbour View
Suffolk, Virginia, 23435
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405
Holy Name Hospital
Teaneck, New Jersey, 07666
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608
About this study
Official title: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)
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.
Read the 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.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
- Being tested
- Interview, Questionnaire Administration
- Keywords
- Prostate, Adenocarcinoma
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Undergo interview
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: 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. Receives: Other: Interview; Other: 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. Receives: Other: Interview; Other: 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. Receives: Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start19 Jul 2019
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963739
- Sponsor's protocol ID
- IRB00056621
- Other IDs
- NCI-2018-03915, P30CA012197, UG1CA189824, NCI-2018-03915, WF-1802
- Acronym
- PCW
- Status last verified
- Jul 2025
- First submitted
- 21 May 2019
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)
- ClinicalTrials.gov ID
- NCT03963739
- Acronym / sponsor ID
- PCW / IRB00056621
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
- Keywords
- Prostate, Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Race: Non-Hispanic African American | – | Other: Interview, Other: Questionnaire AdministrationPatients 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. |
| Race: Non-Hispanic White | – | Other: Interview, Other: Questionnaire AdministrationPatients 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. |
| Income: Lower Income | – | Other: Interview, Other: Questionnaire AdministrationPatients 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. |
| Income: Higher Income | – | Other: Interview, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with adenocarcinoma of the prostate, stage I, II, or III and scheduled to undergo prostatectomy or initiate radiation
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewUndergo interview | Other | Income: Higher Income, Income: Lower Income, Race: Non-Hispanic African American, Race: Non-Hispanic White |
| Questionnaire AdministrationAncillary studies | Other | Income: Higher Income, Income: Lower Income, Race: Non-Hispanic African American, Race: Non-Hispanic White |
Primary outcome
Change in work ability measured by Global Work Ability
Time frame: 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.
8 secondary outcomes
Trajectory of change in work ability at 3 months measured by Global Work Ability
Time frame: Baseline up to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by Global Work Ability
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)
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)
Time frame: Baseline up to 6 months after treatment completion
Trajectory of change in work ability at 3 months measured by employment status
Time frame: Baseline up to 3 months after treatment completion
Trajectory of change in work ability at 6 months measured by employment status
Time frame: Baseline up to 6 months after treatment completion
Difference between preferred and actual length of leave
Time frame: Up to 3 months after treatment completion
Difference between preferred and actual length of leave
Time frame: Up to 6 months after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Lesser, MD study chair
Wake Forest University Health Sciences
326 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Wake Forest University Health Sciences at 326 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 326 sites in United States, Guam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in work ability measured by Global Work Ability (time frame: Baseline up to 6 months after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.