Effect of Treatment on Work Experience in Patients with Stage I-III Prostate Cancer
Prostate Cancer
Unknown Primary
WF-1802 (primary)
WF-1802
WF-1802
NCI-2018-03915
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.
Eligibility
- 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 >= 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
- 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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