GA NCORP

NCORP Trials

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

Status
Closed
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male
Study Type
Supportive care
NCD ID
NCT03963739
Protocol IDs
WF-1802 (primary)
WF-1802
WF-1802
NCI-2018-03915
Study Sponsor
Wake Forest NCORP Research Base

Summary

This trial studies how cancer treatment affects the ability to work in patients with stage I-III prostate cancer. Understanding how treatment affects the ability to work may help researchers create interventions that minimize negative work outcomes and provide treatment decision-making information in patients with stage I-III prostate cancer.

Objectives

PRIMARY OBJECTIVE:
I. 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.

SECONDARY OBJECTIVES:
I. To describe and compare changes in work ability as measured through self-reported global work ability item by race (African American versus white), income (lower versus higher), and time of enrollment (pre or post March 1, 2020; i.e., approximate start of COVID pandemic in United States [US]) in adenocarcinoma of the prostate survivors before treatment and 3 and 6 months after treatment completion.
II. To describe and compare changes in work ability as measured by the Work Limitations Questionnaire by race (African American versus white), income (lower versus higher), and time of enrollment (pre or post March 1, 2020; i.e., approximate start of COVID pandemic in US) in adenocarcinoma of the prostate survivors before treatment and 3 and 6 months after treatment completion.
III. To describe and compare changes in work ability as measured by employment status (employed full-time; employed part-time; not employed) by race (African American versus white), income (lower versus higher), and time of enrollment (pre or post March 1, 2020; i.e., approximate start of COVID pandemic in US) in adenocarcinoma of the prostate survivors before treatment and 3 and 6 months after treatment completion.
IV. Delineate and compare the effects of race, income, and time of enrollment (pre or post March 1, 2020; i.e., approximate start of COVID pandemic in US) on (a) desired and (b) actual length of sick leave at 3 and 6 months after treatment completion for adenocarcinoma of the prostate survivors.

EXPLORATORY OBJECTIVES:
I. To examine if race, income, and the possible impact of COVID-19 on employment moderate the association 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) with regards to:
Ia. Work limitations (as measured by the Work Limitations Questionnaire) at 6 months following completion of radiation therapy or prostatectomy).
Ib. Global Work Ability item at 6 months following completion of radiation therapy or prostatectomy.
Ic. Employment status at 6 months following completion of radiation therapy or prostatectomy.
Id. Preferred and actual length of medical leave at 6-months following completion of radiation therapy or prostatectomy.
II. To explore differences in the outcomes listed in Ia-Id by the timing of enrollment (before or after March 1, 2020) for the moderate to high income, White strata subgroup only and to explore outcomes in Ia-Id for the post-pandemic (after March 1, 2020) cohort by race and income. (Additional exploratory objective)

OUTLINE:
Patients attend an interview over 40-60 minutes before treatment and 3 and 6 months after treatment.