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

• ClinicalTrials.gov Identifier: NCT03963739
• Recruitment Status: Recruiting
• First Posted: May 28, 2019
• Last Update Posted: April 14, 2021
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: May 21, 2019
• First Posted Date: May 28, 2019
• Last Update Posted Date: April 14, 2021
• Actual Study Start Date: July 19, 2019
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 21, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 21, 2019)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 21, 2019)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effect of Treatment on Work Experience in Patients With Stage I-III Prostate Cancer
• Official Title: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

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

Intervention

• Other: Interview
  Undergo interview
• Other: Questionnaire Administration
  Ancillary studies

Study Groups/Cohorts

• 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.
  Interventions:

  • 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.
  Interventions:

  • Other: Interview
  • Other: Questionnaire Administration
• 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.
  Interventions:

  • Other: Interview
  • Other: Questionnaire Administration
• 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.
  Interventions:

  • Other: Interview
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 3, 2021): 255
• Original Estimated Enrollment (submitted: May 21, 2019): 220
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Eligibility 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) 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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 ); NCI-2018-03915 ( Registry Identifier: NCI CTRP ); WF-1802 ( Other Identifier: WF NCORP RB )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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

• Responsible Party: Wake Forest University Health Sciences
• Study Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Joanne Sandberg; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: April 2021