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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963739
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment
Prostate Adenocarcinoma Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Other: Interview Other: Questionnaire Administration

Detailed Description:
This observational, longitudinal study will recruit approximately 220 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
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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: Interview
Undergo interview

Other: Questionnaire Administration
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.
 Other: Interview
Undergo interview

Other: Questionnaire Administration
Ancillary studies
Income: Low 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: Interview
Undergo interview

Other: Questionnaire Administration
Ancillary studies
Income: Moderate to High 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: Interview
Undergo interview

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Trajectory of change in work ability at 3 months measured by Global Work Ability [ Time Frame: 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.

  2. Trajectory of change in work ability at 6 months measured by Global Work Ability [ Time Frame: 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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. Trajectory of change in work ability at 3 months measured by employment status [ Time Frame: 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.

  6. Trajectory of change in work ability at 6 months measured by employment status [ Time Frame: 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.

  7. Difference between preferred and actual length of leave [ Time Frame: Up to 3 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.

  8. Difference between preferred and actual length of leave [ Time Frame: 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.


Other Outcome Measures:
  1. Effect of race and income on treatment-related function, work environment, and type of treatment [ Time Frame: Up to 6 months after treatment completion ]
    Will use interactions to test moderation effects of race and income on the relationship between adenocarcinoma of the prostate treatment-related function (bladder, bowel, and hormonal function), work environment (e.g., work demands, workplace control, and social support), and type of treatment (surgery or radiation therapy, hormonal treatment) regarding outcomes of work limitations (as measured by the Work Limitations Questionnaire), Global Work Ability item, employment status, and preferred and actual length. Work ability, as measured through the WLQ and the Global Work Ability measures, and preferred versus actual length of time off work will be modeled as continuous variables in general linear models; employment status will be modeled as dichotomous (logistic regression) or in a multinomial model depending on the distribution of responses.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with adenocarcinoma of the prostate, stage I, II, or III and scheduled to undergo prostatectomy or initiate radiation
Criteria

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)
  • Intends to be working 6 months from screening
  • 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 sign a written 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963739


Contacts
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Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu

Locations
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United States, Illinois
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
United States, Iowa
Saint Luke's Hospital Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: Site Public Contact    319-368-5514    Rachel.varner@unitypoint.org   
Principal Investigator: Nagendra (Bobby) S. Koneru         
United States, Louisiana
LSU Healthcare Network / Metairie Multi-Specialty Clinic Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joanne Sandberg Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03963739    
Other Study ID Numbers: IRB00056621
NCI-2018-03915 ( Registry Identifier: NCI Trial Identifier )
P30CA012197 ( U.S. NIH Grant/Contract )
UG1CA189824 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: 6 months after publication for a 2 year duration
Access Criteria: upon request to NCORP@wakehealth.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Prostate
Adenocarcinoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type