Changes in older adults' life space during lung cancer treatment: A mixed methods cohort study.

BACKGROUND: Maintenance of function during cancer treatment is important to older adults. Characteristics associated with pretreatment life-space mobility and changes during non-small cell lung cancer (NSCLC) treatment remain unknown. METHODS: This mixed methods cohort study recruited adults age ≥65 with advanced NSCLC starting palliative chemotherapy, immunotherapy, and/or targeted therapy from a Comprehensive Cancer Center, Veterans Affairs, and safety-net clinic. Patients completed geriatric assessments including Life-Space Assessment (LSA) pretreatment and at 1, 2, 4, and 6 months after treatment initiation. LSA scores range from 0 to 120 (greater mobility); LSA <60 is considered restricted. We used mixed-effects models to examine pretreatment LSA, change from 0 to 1 month, and change from 1 to 6 months. A subgroup participated in semistructured interviews pretreatment and at 2 and 6 months to understand the patient experience of life-space change. For each interview participant, we created joint displays of longitudinal LSA scores juxtaposed with illustrative quotes. RESULTS: Among 93 patients, median age was 73 (range 65-94). Mean pretreatment LSA score was 67.1. On average, LSA declined 10.1 points from pretreatment to 1 month and remained stable at 6 months. Pretreatment LSA score was associated with several demographic, clinical, geriatric assessment, and symptom characteristics. LSA decline at 1 month was greater among patients with high anxiety (slope = -12.6 vs. -2.3, p = 0.048). Pretreatment body mass index <21 kg/m2 was associated with LSA improvement from 1 to 6 months (slope = 4.1 vs. -0.04, p = 0.003). Joint displays illustrated the impact of different life-space trajectories on patients' lives in their words. CONCLUSION: Older adults with NSCLC have low pretreatment life space with many developing restricted life space during treatment. Incorporating life-space assessments into clinical cancer care may help older adults concretely visualize how treatment might impact their daily function to allow for informed decision making and identify early changes in mobility to implement supportive interventions.

Progressive Metabolic Dysfunction and Nutritional Variability Precedes Necrotizing Enterocolitis.

Necrotizing Enterocolitis (NEC) is associated with prematurity, enteral feedings, and enteral dysbiosis. Accordingly, we hypothesized that along with nutritional variability, metabolic dysfunction would be associated with NEC onset. Methods: We queried a multicenter longitudinal database that included 995 preterm infants (<32 weeks gestation) and included 73 cases of NEC. Dried blood spot samples were obtained on day of life 1, 7, 28, and 42. Metabolite data from each time point included 72 amino acid (AA) and acylcarnitine (AC) measures. Nutrition data were averaged at each of the same time points. Odds ratios and 95% confidence intervals were calculated using samples obtained prior to NEC diagnosis and adjusted for potential confounding variables. Nutritional and metabolic data were plotted longitudinally to determine relationship to NEC onset. Results: Day 1 analyte levels of alanine, phenylalanine, free carnitine, C16, arginine, C14:1/C16, and citrulline/phenylalanine were associated with the subsequent development of NEC. Over time, differences in individual analyte levels associated with NEC onset shifted from predominantly AAs at birth to predominantly ACs by day 42. Subjects who developed NEC received significantly lower weight-adjusted total calories (p < 0.001) overall, a trend that emerged by day of life 7 (p = 0.020), and persisted until day of life 28 (p < 0.001) and 42 (p < 0.001). Conclusion: Premature infants demonstrate metabolic differences at birth. Metabolite abnormalities progress in parallel to significant differences in nutritional delivery signifying metabolic dysfunction in premature newborns prior to NEC onset. These observations provide new insights to potential contributing pathophysiology of NEC and opportunity for clinical care-based prevention.

Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.

PURPOSE: Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND METHODS: Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS. RESULTS: The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; P = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62; P = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; P = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66; P = .02), but not among hormone receptor-positive patients (HR, 0.89; P = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients. CONCLUSION: With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.

Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity.

BACKGROUND: Holistic approaches are sought to improve lifestyle behaviors and health of cancer survivors long term. OBJECTIVE: Our aim was to explore whether a home-based vegetable gardening intervention is feasible and whether it improves diet and other health-related outcomes among older cancer survivors. DESIGN: We conducted a feasibility trial in which cancer survivors were randomized to receive a year-long gardening intervention immediately or to a wait-list control arm. Home visits at baseline and 1 year assessed physical performance, anthropometric indices, behavioral and psychosocial outcomes, and biomarkers. PARTICIPANTS/SETTING: Participants included 46 older (aged 60+ years) survivors of locoregionally staged cancers across Alabama from 2014 to 2016. Forty-two completed 1-year follow-up. INTERVENTION: Cooperative extension master gardeners delivered guidance to establish three seasonal vegetable gardens at survivors' homes. Plants, seeds, and gardening supplies were provided. OUTCOMES: Primary outcomes were feasibility targets of 80% accrual and retention, and an absence of serious adverse events; other outcomes were secondary and explored potential benefits. STATISTICAL ANALYSES: Baseline to follow-up changes were assessed within and between arms using paired t, McNemar's, and χ2 tests. RESULTS: This trial proved to be safe and demonstrated 91.3% retention; 70% of intervention participants rated their experience as "excellent," and 85% would "do it again." Data suggest significantly increased reassurance of worth (+0.49 vs -0.45) and attenuated increases in waist circumference (+2.30 cm vs +7.96 cm) in the gardening vs control arms (P=0.02). Vegetable and fruit consumption increased by approximately 1 serving/day within the gardening arm from baseline to follow-up (mean [standard error]=1.34 [1.2] to 2.25 [1.9] servings/day; P=0.02)] compared to controls (1.22 [1.1] to 1.12 [0.7]; P=0.77; between-arm P=0.06). CONCLUSIONS: The home vegetable gardening intervention among older cancer survivors was feasible and suggested improvements in vegetable and fruit consumption and reassurance of worth; data also suggest attenuated increases in waist circumference. Continued study of vegetable gardening interventions is warranted to improve health, health behaviors, and well-being of older cancer survivors.

Lymphedema, musculoskeletal events and arm function in older patients receiving adjuvant chemotherapy for breast cancer (Alliance A171302).

PURPOSE: Musculoskeletal events (MEs) resulting from breast cancer treatment can significantly interfere with the quality of life (QOL) of older adults. We evaluated the incidence of MEs in women 65 years and older who had surgery and adjuvant chemotherapy for breast cancer, and the impact of treatment on MEs and arm function. PATIENTS AND METHODS: Patient-reported data in Alliance/CALGB 49907 were collected using the EORTC QLQ-BR23 and physician-reported adverse events to characterize self-reported MEs and incidence of lymphedema. EORTC QLQ-BR23 items related to musculoskeletal events were analyzed in this study and data collected at study entry (post-operative) and 12 and 24 months post-entry. RESULTS: Lymphedema, arm function, and ME data were available for 321 patients. One or more MEs were reported by 87% (median number = 3) and 64% (median number = 1) of patients post-operatively and at 24 months. At 24 months 2% had persistence of six MEs. Seventy-four percent experienced at least ≥3/6 types of MEs over the 24-month period. Detection of lymphedema at any time during the study was noted in 7.5% of the patients and appeared to be associated with the type of chemotherapy given: CMF 16.4%, capecitabine 5.8%, and AC 4%. Mastectomy and axillary node dissection were associated with the most MEs. LROM correlated with poorer arm function at all time periods. CONCLUSION: Potentially debilitating MEs occur in three-fourths of elderly women undergoing standard therapy for breast cancer. Emphasis should be placed on prevention, identification, and treatment of these MEs to improve QOL.

Effect of Pretreatment Renal Function on Treatment and Clinical Outcomes in the Adjuvant Treatment of Older Women With Breast Cancer: Alliance A171201, an Ancillary Study of CALGB/CTSU 49907.

PURPOSE: CALGB 49907 showed the superiority of standard therapy, which included either cyclophosphamide/doxorubicin (AC) or cyclophosphamide/methotrexate/fluorouracil over single-agent capecitabine in the treatment of patients age ≥ 65 with early-stage breast cancer. The treatment allowed dosing adjustments of methotrexate and capecitabine for pretreatment renal function. The purpose of the current analysis was to assess the relationship between pretreatment renal function and five end points: toxicity, dose modification, therapy completion, relapse-free survival, and overall survival. METHODS: Pretreatment renal function was defined as creatinine clearance (CrCl) using the Cockcroft-Gault equation. Multivariable logistic and proportional hazards regression were used to model separately for each regimen the relationship between CrCl and the first three binary end points and the last two time-to-event end points, respectively, after adjusting for variables of prognostic importance. RESULTS: Six hundred nineteen assessable patients were analyzed. The incidence of stage III (moderate) or stage IV (severe) renal dysfunction was 72%, 64%, and 75% for treatment with cyclophosphamide/methotrexate/fluorouracil, AC, and capecitabine, respectively. There was no relationship for any regimen between pretreatment renal function and the five end points. For AC, as CrCl increased, the odds of nonhematologic toxicity decreased (P = .008), whereas for capecitabine, as CrCl increased, the odds of experiencing toxicity of any type also increased (P = .035). Patients with renal insufficiency who received dose modifications were not at increased risk for complications compared with those who did not have renal insufficiency and received a full dose. CONCLUSION: Excluding from clinical trials patients with renal insufficiency but good performance status on the basis of concern of excessive hematologic toxicity or poor outcomes may not be justified with appropriate dosing modifications. Results should be considered in the design of clinical trials for older patients.

Religious vs. conventional cognitive behavioral therapy for major depression in persons with chronic medical illness: a pilot randomized trial.

We examine the efficacy of conventional cognitive behavioral therapy (CCBT) versus religiously integrated CBT (RCBT) in persons with major depression and chronic medical illness. Participants were randomized to either CCBT (n = 67) or RCBT (n = 65). The intervention in both groups consisted of ten 50-minute sessions delivered remotely during 12 weeks (94% by telephone). Adherence to treatment was similar, except in more religious participants in whom adherence to RCBT was slightly greater (85.7% vs. 65.9%, p = 0.10). The intention-to-treat analysis at 12 weeks indicated no significant difference in outcome between the two groups (B = 0.33; SE, 1.80; p = 0.86). Response rates and remission rates were also similar. Overall religiosity interacted with treatment group (B = -0.10; SE, 0.05; p = 0.048), suggesting that RCBT was slightly more efficacious in the more religious participants. These preliminary findings suggest that CCBT and RCBT are equivalent treatments of major depression in persons with chronic medical illness. Efficacy, as well as adherence, may be affected by client religiosity.

Religious involvement is associated with greater purpose, optimism, generosity and gratitude in persons with major depression and chronic medical illness.

OBJECTIVE: Religious involvement may help individuals with chronic medical illness cope better with physical disability and other life changes. We examine the relationships between religiosity, depressive symptoms, and positive emotions in persons with major depression and chronic illness. METHODS: 129 persons who were at least somewhat religious/spiritual were recruited into a clinical trial to evaluate the effectiveness of religious vs. secular cognitive behavioral therapy. Reported here are the relationships at baseline between religious involvement and depressive symptoms, purpose in life, optimism, generosity, and gratefulness using standard measures. RESULTS: Although religiosity was unrelated to depressive symptoms (F=0.96, p=0.43) and did not buffer the disability-depression relationship (B=-1.56, SE 2.90, p=0.59), strong relationships were found between religious indicators and greater purpose, optimism, generosity, and gratefulness (F=7.08, p<0.0001). CONCLUSIONS: Although unrelated to depressive symptoms in the setting of major depression and chronic medical illness, higher religious involvement is associated with positive emotions, a finding which may influence the course of depression over time.

Comorbidity, chemotherapy toxicity, and outcomes among older women receiving adjuvant chemotherapy for breast cancer on a clinical trial: CALGB 49907 and CALGB 361004 (alliance).

PURPOSE: We evaluated associations among comorbidity, toxicity, time to relapse (TTR), and overall survival (OS) in older women with early-stage breast cancer receiving adjuvant chemotherapy. METHODS: Cancer and Leukemia Group B 49907 (Alliance) randomly assigned women ≥ 65 years old with stages I-III breast cancer to standard adjuvant chemotherapy or capecitabine. We reviewed data from 329 women who participated in the quality of life companion study CALGB 70103 and completed the Physical Health Subscale of the Older American Resources and Services Questionnaire. This questionnaire captures data on 14 comorbid conditions and the degree to which each interferes with daily activities. A comorbidity burden score was computed by multiplying the total number of conditions by each condition's level of interference with function. Outcomes were grade 3 to 5 toxicity, TTR, and OS. Logistic regression was used to evaluate associations between comorbidity and toxicity, and Cox proportional hazards models for TTR and survival. RESULTS: Number of comorbidities ranged from 0 to 10 (median 2); the comorbidity burden score ranged from 0 to 25 (median 3). The most common conditions were arthritis (58%) and hypertension (55%). Comorbidity was associated with shorter OS, but not with toxicity or TTR. The hazard of death increased by 18% for each comorbidity (hazard ratio [HR] = 1.18, 95% CI = 1.06 to 1.33) after adjusting for age, tumor size, treatment, node and receptor status. Comorbidity burden score was similarly associated with OS (HR = 1.08; 95% CI, 1.03 to 1.14). CONCLUSIONS: Among older women enrolled onto a clinical trial, comorbidity was associated with shorter OS, but not toxicity or relapse.

Characteristics and treatment options of elderly Chinese patients with cancer as determined by Comprehensive Geriatric Assessment (CGA).

OBJECTIVE: China is experiencing a rapid increase in cancer incidence in elderly patients. In order to better understand this group, a large study of patients from multiple tertiary centers in the Beijing area was designed. This study was designed to provide insight into their unique treatment preferences, including the use of traditional Chinese medicine (TCM). MATERIALS AND METHODS: 803 patients from nine hospitals in the Beijing area were enrolled into this study. The inclusion criteria were patients who were 65 years or older and had a diagnosis of cancer at any stage. The CGA questionnaire used with these patients included the Chinese translation of the Gero-Oncology Health and Quality of Life Assessment tool. The questionnaire was provided to patients by a research nurse and was administered in Mandarin. RESULTS: The mean age of the patients was 72 years (range 65-94). The patients were mainly male (59.8%) and of Han ethnicity (95.4%). About 45% of these patients also had concurrent TCM in addition to their other cancer treatments. About 70% were able to manage their activities of daily living without assistance. Patients on TCM were more likely to have higher number of co-morbidities compared to their counterparts. CONCLUSION: This is the largest prospective study of CGA assessments done on elderly patients with cancer in Asia. The study demonstrates that CGA provides insights into understanding the needs of elderly Chinese patients with cancer. TCM is used frequently in China, and its impact on quality of life needs further investigation.

Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907.

Cognitive changes in older women receiving chemotherapy are poorly understood. We examined self-reported cognitive function for older women who received adjuvant chemotherapy on Cancer and Leukemia Group B (CALGB) 49907. CALGB 49907 randomized 633 women aged ≥65 with stage I-III breast cancer to standard adjuvant chemotherapy (cyclophosphamide-methotrexate-5-fluorouracil or doxorubicin-cyclophosphamide) versus capecitabine. We examined self-reported cognitive function in 297 women (CALGB 361002) who enrolled on the quality of life substudy and had no gross impairment on cognitive screening. Women were evaluated using an 18-item instrument at six time points (baseline through 24 months). At each time point for each patient, we calculated a cognitive function score (CFS) defined as the mean response of items 1-18 and defined impairment as a score >1.5 standard deviations above the overall average baseline score. Differences in scores by patient characteristics were evaluated using a Kruskal-Wallis test. A linear mixed-effects model was used to assess CFSs by treatment over time. Among 297 women, the median age was 71.5 (range 65-85) and 73 % had performance status of 0. Baseline depression and fatigue were reported in 6 and 14 % of patients, respectively. The average CFS at baseline was 2.08 (corresponding to "normal ability"), and baseline cognitive function did not differ by treatment regimen (p = 0.350). Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed. In a healthy group of older women, chemotherapy was not associated with longitudinal changes in self-reported cognitive function.

Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: a companion study to cancer and leukemia group B 49907.

PURPOSE: A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy. PATIENTS AND METHODS: QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months. CONCLUSION: Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.

Why John wasn't healed by prayer: perspectives across disciplines.

Patients and family members often turn to prayer in response to serious, life-threatening illness. Prayer for a miraculous cure is often the request. While prayer can keep hope alive, it may also promote unrealistic expectations that fuel demands for life-preserving technology in medically futile situations. Furthermore, if prayer does not achieve the desired results, then disappointment and disillusionment may follow and make the coping process even more difficult. We present here a case of a seriously ill man whose family and faith community prayed for his healing. John, however, was not healed. A medical internist, two psychiatrists, a sociologist, and a theologian discuss their perspectives on the apparent failure of prayer to heal John. This cross-disciplinary discussion reveals insights that we believe physicians can use when confronting such issues with patients.

Extracellular glutathione peroxidase (Gpx3) binds specifically to basement membranes of mouse renal cortex tubule cells.

Glutathione peroxidase-3 (Gpx3), also known as plasma or extracellular glutathione peroxidase, is a selenoprotein secreted primarily by kidney proximal convoluted tubule cells. In this study Gpx3(-/-) mice have been produced and immunocytochemical techniques have been developed to investigate Gpx3 metabolism. Gpx3(-/-) mice maintained the same whole-body content and urinary excretion of selenium as did Gpx3(+/+) mice. They tolerated selenium deficiency without observable ill effects. The simultaneous knockout of Gpx3 and selenoprotein P revealed that these two selenoproteins account for >97% of plasma selenium. Immunocytochemistry experiments demonstrated that Gpx3 binds selectively, both in vivo and in vitro, to basement membranes of renal cortical proximal and distal convoluted tubules. Based on calculations using selenium content, the kidney pool of Gpx3 is over twice as large as the plasma pool. These data indicate that Gpx3 does not serve in the regulation of selenium metabolism. The specific binding of a large pool of Gpx3 to basement membranes in the kidney cortex strongly suggests a need for glutathione peroxidase activity in the cortical peritubular space.

Adjuvant chemotherapy in older women with early-stage breast cancer.

BACKGROUND: Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS: We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor-positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS: When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P<0.001). Patients who were randomly assigned to capecitabine were twice as likely to have a relapse and almost twice as likely to die as patients who were randomly assigned to standard chemotherapy (P=0.02). At 3 years, the rate of relapse-free survival was 68% in the capecitabine group versus 85% in the standard-chemotherapy group, and the overall survival rate was 86% versus 91%. Two patients in the capecitabine group died of treatment-related complications; as compared with patients receiving capecitabine, twice as many patients receiving standard chemotherapy had moderate-to-severe toxic effects (64% vs. 33%). CONCLUSIONS: Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. (ClinicalTrials.gov number, NCT00024102.)

Dietary supplement use among elderly, long-term cancer survivors.

INTRODUCTION: The purpose of the present study was to assess dietary supplement use and its association with micronutrient intakes and diet quality among older (>or=65 years), long-term survivors (>or=5 years post-diagnosis) of female breast, prostate, and colorectal cancer. METHODS: The sample included 753 survivors who participated in telephone screening interviews to determine eligibility for a randomized diet and physical activity intervention trial entitled RENEW: Reach-out to ENhancE Wellness in Older Cancer Survivors. Telephone surveys included two 24-hour dietary recalls and items regarding supplement use (type, dose, and duration). Nutrient intakes were compared to Dietary Reference Intakes (DRIs). Diet quality was assessed using the revised Healthy Eating Index (HEI). Descriptive statistics and multivariate logistic regression were used in this cross-sectional study. RESULTS: A majority of survivors (74%) reported taking supplements, with multivitamins (60%), calcium/vitamin D (37%), and antioxidants (30%) as the most prevalent. Overall proportions of the total sample with dietary intakes below Estimated Average Requirements (EARs) were substantial, although supplement users had more favorable mean HEI scores (P < 0.01) and nutrient intakes for 12 of the 13 vitamins and minerals investigated (P values < 0.05). Supplement use was positively associated with older age (>or=70 years) (odds ratio (OR)=1.70; 95% confidence interval (95% CI)=1.17, 2.46) and female gender (OR=1.49; 95% CI=1.04, 2.13), and negatively associated with current smoking (OR=0.40, 95% CI=0.21, 0.76). Individuals scoring higher on the Total Fruit (OR=1.12, 95% CI=1.01, 1.23), Whole Grain (OR=1.14, 95% CI=1.04, 1.25), and Oil (OR=1.10, 95% CI=1.01, 1.11) components of the HEI were significantly more likely to take supplements, while those scoring higher on the Meat and Beans category (OR=0.81, 95% CI=0.71, 0.93) were significantly less likely to take supplements. Compared to those with less than a high school education, survivors with a professional or graduate degree were significantly more likely to use supplements (OR=2.18, 95% CI=1.13, 4.23). DISCUSSIONS/CONCLUSIONS: Demographic, disease, and health-related correlates of supplement use follow similar trends observed in the general population as well as previous reports from other cancer survivor populations. Supplement use may reduce the prevalence of nutrient inadequacies in this population, though survivors who use supplements are the least likely to need them. IMPLICATIONS FOR CANCER SURVIVORS: Supplement use may be an effective means for many survivors to achieve adequate nutrient intakes; however, open communication between healthcare providers and survivors is needed to ensure potential concerns are addressed as supplement use may not always be beneficial.

Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.

Data Safety Monitoring Committees (DSMB) for large, long-term randomized trials of agents in common use face challenging problems especially when the emerging data indicate unanticipated effects. The DSMB for the Women's Health Initiative Clinical Trials, on observing early indication of a surprising adverse cardiovascular effect of post-menopausal hormones, spent several years deliberating what recommendations it should make. This paper describes the dilemmas faced by the DSMB and the considerations it made over the course of its existence. The paper concludes with some recommendations for other DSMBs.

The association between oral health and general health and quality of life in older male cancer patients.

OBJECTIVES: To describe the long-term effects of oral health problems on quality of life (QoL), functional status, pain, and general health in older male cancer patients. DESIGN: Secondary analysis of a prospective observational study. SETTING: Community dwelling cancer patients served by a Department of Veterans Affairs hospital. PARTICIPANTS: One hundred fifty male cancer patients responded to the question "Do you have tooth or mouth problems making it hard to eat?" The relationship between patients answering "yes" and the following parameters was assessed: demographics, comorbid conditions, habits, activities of daily living, pain, anxiety, depression, social support, spirituality, QoL, and overall health ratings. MEASUREMENTS: Chi-square contingency tables for dichotomous variables, Cochran-Mantel-Haenszel for ordered categorical variables, and t tests for associations with continuous variables. RESULTS: The median age of respondents was 67. Those reporting tooth or mouth problems had had their cancer diagnosed on average 2.9 years before, and 83.3% were found clinically to be cancer free. Patients with these problems had significantly lower global (P=.003) and subscale scores on QoL analysis and higher levels of anxiety (P<.001) and depression (P=.01) than those without tooth or mouth problems; they also had significantly more pain (P<.001) and lower physical functioning (P<.001) and were more impaired in activities of daily living (P<.001). Those with tooth or mouth problems were more likely to describe their overall health as fair or poor (P=.01). Having cancer located in the head and neck region related significantly to having mouth or tooth problems (P=.005), but these problems were not associated with race, education, income, insurance coverage, age, comorbid conditions, alcohol consumption, tobacco or medication usage, type of cancer treatment, tumor stage at diagnosis or follow-up, perceived social support, or spirituality. CONCLUSION: Older male cancer patients with mouth or tooth problems making it hard to eat are more likely to have a lower QoL, poorer emotional health, lower levels of physical functioning, and greater pain than patients without these problems.