Psychosocial factors and treatment satisfaction after radical prostatectomy

More than 164,690 men are expected to be diagnosed with prostate cancer in the United States in 2018.¹ Men with prostate cancer face not only stress associated with the diagnosis but also decisional conflict regarding different treatment options.² Most men diagnosed with clinically localized prostate cancer receive 1 or more of the following treatments: radical prostatectomy, external-beam radiation therapy, and/or brachytherapy, all of which are associated with posttreatment urological or sexual side effects including bowel, urinary, or erectile dysfunction.^3-5 Men who choose active surveillance may experience increased anxiety associated with the constant vigilance and monitoring of their tumor status along with the uncertainty of not definitively removing or radiating their prostate.⁶ In addition to direct functional limitations of sexual and urological side effects, treatment can also lead to secondary psychosocial effects, including depression, self-blame, embarrassment, guilt, lower masculine self-esteem, increased reticence to participate socially or engage in sexual activity, and relationship distress.^7-9 Therefore, health-related quality of life (HRQoL) and treatment satisfaction are important for this population.

Urological and sexual side effects of prostate cancer treatments are often a primary focus during treatment decision making between patients and providers. However, little prospective empirical data exist regarding the role of HRQoL and other nonurological physical and psychosocial outcomes on overall treatment satisfaction. The purpose of this study was to prospectively evaluate the role of both urological and nonurological outcomes on overall treatment satisfaction in men diagnosed with prostate cancer. We hypothesize that such an understanding can help describe changes in physical and psychosocial factors that are important to men beyond traditional urological outcomes, including their association with overall treatment satisfaction.
 

Methods

This was a prospective longitudinal assessment of patients from the Department of Urology at Northwestern University’s Feinberg School of Medicine in Chicago. Patients were eligible if they met the following inclusion criteria: they had been diagnosed with clinically localized or locally advanced prostate cancer; they had not yet received a primary treatment (eg, surgery, radiation, active surveillance) before their baseline assessment; they were 18 years or older; and they were able to read, write, speak, and understand English. Patients were excluded if they had a physical debilitation that would make participation not feasible or would create undue hardship, or if they had a history of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians.

Eligible participants were approached before their treatment decision (if any). Patient enrollment occurred in 2 ways. For patients invited to participate during their clinic visit, the research assistant explained the study and obtained written informed consent for interested patients. A unique user identification and password was created for each patient, and they practiced using the touch screen computer while the research assistant observed and provided guidance as needed. When the patients were ready to start their pretreatment online interview, they completed the questionnaires by themselves. For patients who were invited to participate but were not scheduled to return in the foreseeable future, enrollment was carried out differently. In those cases, participating physicians contacted eligible patients who were not scheduled for a visit and informed them of the study opportunity. Interested patients were contacted by the research assistant who provided them with the study website address, which directed them to the online consent form. After a patient had completed the consent form, he was prompted to self-register. He received a unique user identification and password that could be used to complete the baseline assessment and subsequent assessments. However, for interested patients who did not have access to a computer or Internet connection, the research assistant provided them with paper consent forms and paper versions of all study assessments. After participants had completed the baseline assessment, the research assistant provided them with a written schedule of future assessments, which were expected to occur at 1 month posttreatment, 3 months posttreatment, 6 months posttreatment, and 12 months posttreatment.

For all follow-up appointments, participants could complete assessments either at clinic visits or from home using a secure online assessment platform called Assessment Center.¹⁰ The research assistant used a patient log to track participants and their progress in the study, which included study number, patient name (or initials), registration date, date of birth, sex, and timeline of completed or future assessments. The research assistant called or emailed participants (depending on patient preference) about a week before each of their follow-up assessments to facilitate adherence. If the participant did not log into the system by the target day, the research assistant contacted him the following day (target day +1) with a phone or email reminder to log into the system and complete the assessments. If the participant did not log in by midnight 1 day after the target day, the research assistant attempted to contact him one last time (target day +2) with either a reminder to log into the system or to ascertain his status that might be related to his noncompletion. Overall, a participant was called or e-mailed 1 to 3 times to remind him of his assessment. If he was unresponsive after 3 attempts, he was recorded as having withdrawn for an unknown reason.

At baseline and each follow-up time point, study participants completed a battery of patient-reported outcome measures, with most coming from the Patient-Reported Outcomes Measurement Information System (PROMIS)¹¹ and the Surgical Outcomes Measurement System (SOMS).¹² PROMIS is a National Institutes of Health (NIH) funded measurement system that has helped standardize and improve self-reported assessment of health status, symptoms, side effects, and different aspects of HRQoL, including physical, emotional, cognitive, and social health. SOMS is a suite of patient-reported outcome measures assessing important aspects of HRQoL after surgery. It was developed with feedback from surgeons, postoperative patients, and surgical nurses. PROMIS items were directly incorporated into numerous SOMS measures to facilitate easier comparisons and score crosswalks across measures and patient populations. In addition to PROMIS and SOMS measures, we also administered several well-known instruments of urological and sexual function, including the International Index of Erectile Function (IIEF) and American Urological Association Symptom Score Index (AUASS).^13,14

Outcome measures were compared across sociodemographic and clinical variables at each time point using t tests for numerical variables (age) and with chi-square or Fisher exact tests for categorical variables; those variables with significant differences were used as covariates in statistical models. To examine differences in patient-reported scores over time, we used repeated measures analysis of covariance with general linear modeling methods. We used Pearson correlation coefficients to evaluate for correlations between quality-of-life outcomes and treatment satisfaction.

Not all participants completed each of the follow-up surveys, and reasons for dropout were prospectively documented. Most participants elected surgical resection as their primary treatment compared with the fewer than 10% of patients who chose radiation or chemotherapy as their primary treatment and about 20% of men who chose active surveillance after their initial diagnosis. Therefore, our analysis focused on patients who elected surgical resection. For comparison purposes, we included the HRQoL results from active surveillance patients.