Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial.

UNLABELLED: Study Type--Therapy (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Patient-reported quality of life (QoL) in prostate cancer is recognized as an important outcome, and has been shown in multiple studies to capture the incidence and timing of patient symptoms more accurately than physician-graded toxicity reports. Although the long-term QoL after completing radiation therapy (RT) has been previously studied, patient experience during RT is not well described in the literature. The present study collected patient-reported QoL during RT in a prospective phase II clinical trial. The study describes in detail the time course and severity of gastrointestinal and genitourinary symptoms during radiation, providing clinically useful information for patients and physicians considering RT during the treatment decision-making process. OBJECTIVE: • To evaluate data collected from a phase II trial to describe the time course and trajectory of patient-reported acute urinary and bowel symptom development during radiation therapy (RT) for prostate cancer. PATIENTS AND METHODS: • In all, 100 patients with intermediate- or high-risk prostate cancer received 72 Gy of RT to the prostate and seminal vesicles, with 6 months of concurrent androgen deprivation therapy; a rectal balloon was used for prostate immobilization. • Patients completed the validated Prostate Cancer Symptom Indices questionnaire every 1-2 weeks, reporting urinary and bowel symptoms on a four- or five-point Likert scale. • A score of ≥ 3 in a symptom is associated with clinically meaningful distress. Cumulative incidence of each symptom is reported. Bonferroni corrections of P values were used to adjust for multiple comparisons. RESULTS: • Urinary symptoms were frequent at baseline and worsened during treatment. By the end of RT, 28-50% of patients developed clinically meaningful obstructive and irritative urinary symptoms. • Acute bowel symptoms were less frequent. Each bowel symptom increased in frequency by 9-26% from baseline to end of RT. • Urinary incontinence was rare. • Overall, symptom burden at the end of treatment was modest. CONCLUSIONS: • Urinary symptoms were common during RT, and bowel symptoms were less frequent. • These results inform patients and physicians during the decision-making process about potential patient quality of life experiences during RT, and also provide a benchmark for comparative effectiveness studies against newer treatments and technologies.

Data pooling and analysis to build a preliminary item bank: an example using bowel function in prostate cancer.

Assessing bowel function (BF) in prostate cancer can help determine therapeutic trade-offs. We determined the components of BF commonly assessed in prostate cancer studies as an initial step in creating an item bank for clinical and research application. We analyzed six archived data sets representing 4,246 men with prostate cancer. Thirty-one items from validated instruments were available for analysis. Items were classified into domains (diarrhea, rectal urgency, pain, bleeding, bother/distress, and other) then subjected to conventional psychometric and item response theory (IRT) analyses. Items fit the IRT model if the ratio between observed and expected item variance was between 0.60 and 1.40. Four of 31 items had inadequate fit in at least one analysis. Poorly fitting items included bleeding (2), rectal urgency (1), and bother/distress (1). A fifth item assessing hemorrhoids was poorly correlated with other items. Our analyses supported four related components of BF: diarrhea, rectal urgency, pain, and bother/distress.

The effects of mammographic detection and comorbidity on the survival of older women with breast cancer.

OBJECTIVES: To determine an upper age limit or quantifiable level of comorbidity that would render mammography screening ineffectual in decreasing mortality in women aged 65 and older. DESIGN: Retrospective cohort study. SETTING: Upper midwestern United States. PARTICIPANTS: Five thousand one hundred eighty-six predominantly Caucasian women aged 65 to 101 diagnosed with invasive breast cancer from 1986 through 1994. Data were obtained from The Upper Midwest Tumor Registry System, a regional consortium database in Minnesota, North Dakota, and South Dakota. MEASUREMENTS: Relative risks (RRs) of death were computed for patients with mammographically detected tumors, stratified by age and comorbidity. Survival analysis was performed, stratified by level of comorbidity and method of tumor detection. RESULTS: Patients with mammographically detected tumors and no comorbidity experienced significantly lower RRs of death in every age group (range P <.001 to P =.039). Women with mammographically detected tumors and mild to moderate comorbidity had RRs of death as follows: age 65 to 69 (RR = 0.32, 95% confidence interval (CI) = 0.15-0.69), age 70 to 74, (RR = 0.45, 95% CI = 0.22-0.91); age 75 to 79 (RR = 0.47, 95% CI = 0.25-0.88), age 80 and older (RR = 0.52, 95% CI = 0.33-0.80). Women with severe or multiple comorbidities experienced no improvement in survival with mammographically detected tumors. CONCLUSIONS: Mammographic detection of breast cancer may be associated with a significantly decreased risk of death for older women of all ages, even for women with mild to moderate levels of comorbidity, but for older women with severe or multiple comorbidities, mammography is not associated with improvement in overall survival.

A nurse-based pilot program to reduce cardiovascular risk factors in a primary care setting.

OBJECTIVE: To evaluate the effectiveness of a nurse-based cardiovascular disease (CVD) risk factor reduction program among patients at a primary care outpatient clinic. STUDY DESIGN: Preintervention and postintervention longitudinal, prospective pilot study to evaluate patients' achievement of CVD risk factor reduction. PATIENTS AND METHODS: A total of 436 patients at a primary care clinic in suburban Minneapolis, Minnesota, were enrolled in 2 years; 286 patients were followed up with additional visits. The nurse intervention included comprehensive CVD risk assessment, patient education, and counseling. Algorithms guided the development of individualized care plans based on laboratory test values, blood pressure readings, tobacco use, and history of cardiovascular events. Physicians were consulted for serious changes in patients' medical conditions or for medication changes. Three measures were compared from baseline to the end of the program: blood pressure, low-density lipoprotein cholesterol levels, and tobacco use. RESULTS: Statistically significant reductions were achieved from baseline to the final nurse visit in systolic blood pressure (from 155.8 to 143.4 mm Hg), diastolic blood pressure (from 94.4 to 84.0 mm Hg), and dyslipidemia (low-density lipoprotein cholesterol, from 4.15 to 3.80 mmol/L [from 160 to 147 mg/dL]) (P < .001 for all). Of the 40 tobacco users who participated in the program, 12 discontinued use (30%). CONCLUSIONS: This pilot study provides preliminary evidence of the effectiveness of a nurse-based CVD risk reduction program. Further study is needed to target high-risk patients and to compare results in the nurse intervention group with those in patients receiving usual care.

Evaluating a risk-based model for mammographic screening of women in their forties.

BACKGROUND: A risk-based model was developed for recommendations for mammography screening of women in their 40s. We determined retrospectively the proportion of women already diagnosed in their 40s with breast cancer (BC) who would have been recommended for mammography screening by this model. METHODS: Information was obtained from 404 women who were diagnosed with BC in their 40s from 1990 to 1998 at a large midwestern hospital. Data on BC detection method, mammography history, and BC risk factors existing before diagnosis were obtained from 353 of these women by mailed questionnaires. Data for an additional 51 women who had died were obtained by chart review. Two algorithms, the Exact Age Procedure (EAP) and the Grouped Age Procedure (GAP), were used to calculate the proportion of women who would have been recommended for mammography screening based on age, race, and BC risk factors. RESULTS: Of women diagnosed with BC in their 40s, 74.5% would have been recommended for screening by the EAP and 70.5% by the GAP. The model would have recommended screening for approximately one half of the women who had no conventional risk factors (54% by EAP, 48% by GAP). CONCLUSION: Although use of the risk-based model could result in more recommendations for screening than individual recommendations based on patient-physician discussions about the woman's risk factors, one in four women diagnosed with breast cancer in their 40s would not have been recommended for mammography screening.