Skip to Main Content

COVID-19 is an emerging, rapidly evolving situation.

What people with cancer should know: https://www.cancer.gov/coronavirus

Get the latest public health information from CDC: https://www.coronavirus.gov

Get the latest research information from NIH: https://www.nih.gov/coronavirus

Principal Investigator
Name
Katherine Taylor
Institution
Georgetown University - Lombardi Center
Email
About this CDAS Project
Study
PLCO (Learn more about this study)
Project ID
2006-0248
Initial CDAS Request Approval
Jul 1, 2006
Title
Quality of Life in Men Diagnosed with Prostate Cancer and in a Healthy Cohort
Summary
Background: Prostate cancer (PCa) is the leading cancer diagnosis among men and the third leading cause of male cancer death, with 27,350 deaths expected in 2006. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial is addressing whether early detection and treatment of PCa can reduce disease-related mortality. The proposed retrospective cohort study will be the first study to examine the long-term health-related quality of life (HRQL) sequelae of prostate cancer in the PLCO trial. As PCa screening rates in the US are increasing, and men are living increasingly longer with PCa, studies of HRQL outcomes need to document the long-term impact of diagnosis and treatment. It is critical to understand if the quality of the years gained living with prostate cancer justifies the use of screening. Objective: The primary goal of this study is to delineate the impact of regular screening among long-term PCa survivors, as well as to separate the consequences of PCa disease and treatment vs. the consequences of aging. Specific Aims: 1) To document the extent of urinary, sexual, and bowel dysfunction and general HRQL in a sample of PCa survivors who are 5 to 10 years post-diagnosis, compared to a sample of men who have not been diagnosed with cancer. 2) Within the PCa survivor cohort, we will assess the impact of treatment modality on symptomatology and HRQL. 3) Based on the previous literature, we expect to find no difference on general HRQL between 1) men with PCa vs. the healthy comparison group or 2) between different treatment modalities. We will test this hypothesis using a standard equivalence approach. Exploratory Aims: Among men without PCa, we will assess the HRQL impact of receiving multiple false positive screening exams. Among men who were current or former smokers at the PLCO baseline, we will assess whether tobacco use has changed since this assessment and if the change in tobacco use mediates HRQL. Study Design: To address these research questions, we propose a retrospective cohort study within the PLCO trial. We will quantify the complications of the disease, treatments, and aging, including the extent of physical symptoms and general and disease-specific HRQL. Participants with PCa, diagnosed 5-10 years previously, will include men with screen-detected PCa from the screening arm (Group 1; N = 250) and men diagnosed with PCa from the usual care arm (Group 2; N = 250). We will compare the PCa patients to a cohort of PLCO participants with no cancer diagnosis from the screening arm (Group 3; N = 250) and from the usual care arm (Group 4; N = 250). We will accrue participants from 5 of the 10 PLCO Screening Centers and will assess current symptomatology and HRQL via telephone interview. Cancer Relevance: The proposed study will provide crucial information for men and health care providers who are making difficult decisions regarding whether to undergo screening and/or treatment for localized PCa. Until there is a definitive demonstration of a mortality reduction associated with early detection, the quality of life of men who undergo screening must be central to the development of PCa screening policies.
Aims

We will quantify the complications of the disease, treatments, and aging, including the extent of physical symptoms and general and disease-specific HRQL. Participants with PCa, diagnosed 5-10 years previously, will include men with PCa from the screening arm (Group 1; N = 250) and men diagnosed with PCa from the usual care arm (Group 2; N = 250). We will compare the PCa patients to randomly selected sub-samples of PLCO participants with no cancer diagnosis from the screening arm (Group 3; N = 250) and from the usual care arm (Group 4; N = 250). We will accrue participants from 5 of the 10 PLCO Screening Centers and will assess current symptomatology and HRQL via telephone interview. The specific aims are: 1) To document the extent of urinary, sexual, and bowel dysfunction and cancer-specific HRQL in a sample of PCa survivors who are 5 to 10 years post-diagnosis, compared to a sample of men who have not been diagnosed with cancer. These analyses will include Groups 1 and 2 vs. 3 and 4. H.1.1: PCa survivors will report overall poorer physical functioning (i.e., urinary, sexual, bowel) relative to the participants without PCa, adjusting for age, race, comorbidities, screening center, trial arm, and time since trial enrollment. H.1.2: Time since trial enrollment will moderate the differences between PCa survivors and men without PCa, such that the two groups will be more similar on the outcomes as time since enrollment increases. H.1.3. We will explore the interaction between trial arm (screening/UC) and PCa status (present/absent) to determine whether HRQL following a PCa diagnosis is differentially affected by receipt of regular screening. We hypothesize that men diagnosed in the screening arm will report relatively fewer or less severe symptoms and better cancer-specific HRQL compared to men diagnosed in the usual care arm (Groups 1 vs. 2), whereas we do not expect to find a difference between the trial arms among men without cancer (Groups 3 vs. 4). 2) Within the PCa survivor cohorts, we will assess treatment-related symptoms and cancer-specific HRQL. We will adjust for demographic and trial-related confounding variables (e.g., race, age, disease stage at diagnosis, comorbidities, time since diagnosis, and screening center). H.2: We hypothesize that surgery will result in the poorest sexual and urinary functioning outcomes, while radiation and radiation plus hormone therapy will result in the poorest bowel functioning outcomes. This analysis will combine Groups 1 and 2 and adjust for trial arm and the other potential confounders. 3) Based on the previous literature, we expect to find no difference on general HRQL between a) men with PCa (Groups 1 and 2) vs. the healthy comparison groups (Groups 3 and 4), or b) between different treatment modalities (Groups 1 and 2 combined). We will test this hypothesis using a standard equivalence approach.

Related Publications