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Biomedical subjects

Paul Novotny

Publications and source records attributed to Paul Novotny.

16 recordsLinked to original sources
PubMed2006

A patient orientation program at a comprehensive cancer center.

PURPOSE/OBJECTIVES: To determine which method of delivery of a cancer orientation program contributed to higher levels of satisfaction and lower levels of anxiety for newly diagnosed patients with cancer and each patient's support person. DESIGN: A randomized study of patients with cancer and caregivers into one of three delivery methods for an orientation program or a control arm. SETTING: A National Cancer Institute-designated comprehensive cancer center in the midwestern United States. SAMPLE: Newly registered patients with cancer diagnoses and their identified support people. METHODS: The intervention consisted of an orientation video and booklet delivered by three separate methods: class, drop-in sessions, or information mailed to homes. Participants completed questionnaires before the intervention and three weeks after the intervention. MAIN RESEARCH VARIABLES: State and trait anxiety, satisfaction, understanding of the organization, awareness and use of resources, and stress and coping. FINDINGS: The most successful accrual arms were the mailed intervention and control groups. The mailed intervention group compared to the control group reported higher levels of satisfaction with the cancer center, satisfaction with resources, understanding of the cancer center's structure, and satisfaction with healthcare professionals' communication with them. Fewer intervention group participants reported a lack of awareness of specific resources, and a larger percentage of the intervention group used available resources. Fewer benefits were noted with caregivers. CONCLUSIONS: The mailed intervention was successful in improving several patient outcomes. It was shown to be especially helpful to those with high trait anxiety. IMPLICATIONS FOR NURSING: A mailed orientation program can be a useful approach for increasing satisfaction with services.

Caregivers↗
PubMed2006

Pilot evaluation of bupropion for the treatment of hot flashes.

Bupropion is commonly used in the treatment of nicotine dependence and depression, and in most people, does not cause sexual dysfunction, weight gain, or sedation. Given its attractive side effect profile, the efficacy of other newer antidepressants against hot flashes and anecdotal observations of resolution of hot flashes in some patients taking bupropion for nicotine dependence, it was decided to explore its clinical activity as a hot flash remedy in a pilot study. Between January 1999 and October 2004, 21 patients (7 men and 14 women) were enrolled in the study. Self-completed daily hot flash diaries were used to document the frequency and severity of hot flashes at baseline (week 1) and during the treatment period (weeks 2 through 5). Participants received bupropion 150 mg every morning for the first 3 days and then 150 mg twice per day for a total of 4 weeks. One woman did not provide any hot flash information and was excluded from the analysis. Five women could not complete the study because of side effects. The study did not show a reduction in hot flash frequency and/or severity significantly higher than what would be expected with a placebo. Even though the sample size was small, these results are consistent with bupropion's mechanism of action (norepinephrine reuptake inhibition without serotonergic effects) and what it is now hypothesized about the pathophysiology of hot flashes (increased noradrenergic activity and decreased serotonergic activity). These data suggest that bupropion should not be further investigated as a remedy for hot flashes.

Adolescent↗
PubMed2005

The prevalence of weight concerns in a smoking abstinence clinical trial.

Recent research has demonstrated there is a high prevalence of weight concerns in smokers and that smokers with weight concerns may respond poorly to treatment for tobacco dependence. Most studies have focused only on females or have consisted of small samples. In this study of a 12-week randomized trial of nicotine inhaler, bupropion or both for smoking cessation, 50% of the 1012 female smokers and 26% of the 680 male smokers, at study entry, were weight concerned. In examining the impact of weight concerns on the 12-week point-prevalence smoking abstinence, 26% of non-weight-concerned smokers quit smoking compared to 22% of weight-concerned smokers (p=0.06). This study, which includes a large sample of both genders, provides further evidence that approximately half of females who are seeking smoking cessation treatment are weight concerned and that one quarter of male smokers are weight concerned. Additionally, being weight concerned may impact the short-term success rates of stopping smoking using pharmacotherapy.

Adult↗
PubMed2005

The well-being and personal wellness promotion strategies of medical oncologists in the North Central Cancer Treatment Group.

PURPOSE: The well-being of oncologists is important to the well-being of their patients. While much is known about oncologist distress, little is known about oncologist well-being. We set out to evaluate oncologist well-being and the personal wellness promotion strategies used by oncologists. PATIENTS AND METHODS: We performed a cross-sectional survey of medical oncologists in the North Central Cancer Treatment Group using a validated instrument to measure quality of life. Study-specific questions explored stressors, wellness promotion strategies and career satisfaction. RESULTS: Of 241 responding oncologists (response rate 61%), 121 (50%) reported high overall well-being. Being age 50 or younger (57 vs. 41%; p = 0.01), male (53 vs. 31%; p = 0.01) and working 60 h or less per week (50 vs. 33%; p = 0.005) were associated with increased overall well-being on bivariate analysis. Ratings of the importance of a number of personal wellness promotion strategies differed for oncologists with high well-being compared with those without high well-being. Developing an approach/philosophy to dealing with death and end-of-life care, using recreation/hobbies/exercise, taking a positive outlook and incorporating a philosophy of balance between personal and professional life were all rated as substantially more important wellness strategies by oncologists with high well-being (p values <0.001). Oncologists with high overall well-being also reported greater career satisfaction. CONCLUSION: Half of medical oncologists experience high overall well-being. Use of specific personal wellness promotion strategies appears to be associated with oncologist well-being. Further investigations of the prevalence, promotion, causes, inequities and clinical impact of physician well-being are needed. .

Adult↗
PubMed2005

Relationship between increased personal well-being and enhanced empathy among internal medicine residents.

BACKGROUND: While resident distress and its potential to negatively effect patient care have been well documented, little is known bout resident well-being or its potential to enhance care. OBJECTIVE: We measured resident well-being and explored its relationship with empathy. DESIGN: Anonymous, cross-sectional survey. PARTICIPANTS: Internal medicine residents at Mayo Clinic Rochester (n=165, summer 2003). MEASUREMENTS: Well-being was measured using the previously validated Medical Outcomes Study 8-item Short Form (SF-8). Empathy was measured using the previously validated Perspective Taking (PT) and Empathetic Concerns (EC) Sub-scales of the Interpersonal Reactivity Index (IRI). RESULTS: Eighty-three (50%) residents responded to the survey. Mean scores for well-being as measured by the SF-8 were comparable to the general population, and empathy scores on the IRI were similar to other resident samples. Resident empathy on both the cognitive (PT) and emotive (EC) sub-scales of the IRI was higher for residents with higher mental well-being on the SF-8; however, this difference was statistically significant only for the cognitive sub-scale. The importance of a number of personal wellness promotion strategies differed for residents with higher mental well-being on the SF-8. CONCLUSIONS: High mental well-being was associated with enhanced resident empathy in this cross-sectional survey. Future studies need to explore the potential for high resident well-being to enhance medical care and competency in addition to exploring the negative consequences of resident distress. Studies investigating how to promote resident well-being are needed.

Adult↗
PubMed2004

A pilot study on safety and pharmacokinetics of infliximab for the cancer anorexia/weight loss syndrome in non-small-cell lung cancer patients.

BACKGROUND: Weight loss predicts a poor prognosis for patients with non-small-cell lung cancer. Tumor necrosis factor alpha (TNFalpha) is a mediator of this weight loss, yet no studies have tested infliximab, an IgG monoclonal antibody that blocks the binding of TNFalpha to its p55 and p75 receptors, for this indication. The safety and pharmacokinetics of infliximab in combination with docetaxel, a commonly used chemotherapy agent for non-small-cell lung cancer, were explored in this pilot study. METHODS/RESULTS: Four patients with metastatic non-small-cell lung cancer were treated initially with infliximab 5 mg/kg per day intravenously once a week on weeks 1, 3 and 5, and docetaxel 36 mg/m2 per day intravenously once a week on weeks 1, 2, 3, 4, 5 and 6 of an 8-week treatment cycle. Therapy was well tolerated with no grade 4 or 5 adverse events. Maximal serum concentrations of infliximab at 1, 3 and 5 weeks were (mean+/-SD) 108+/-11, 135+/-19, and 139+/-6 microg/ml, respectively, and appeared similar to historical concentrations from non-cancer patients not receiving concomitant chemotherapy (144+/-68 microg/ml). One patient manifested weight stability. One patient manifested a partial tumor response, one stable disease, and two disease progression. Median survival within the cohort was 203 days (range 111 to 324 days). CONCLUSIONS: The above combination appears safe, and docetaxel does not appear to increase serum concentrations of infliximab. A larger study testing the role of this combination for weight loss in non-small-cell lung cancer patients is ongoing and utilizes the doses described above.

Aged↗
PubMed2004

Are chemotherapy response rates related to treatment-induced survival prolongations in patients with advanced cancer?

PURPOSE: Patients with incurable cancer are faced with difficult decisions regarding whether to take chemotherapy in an attempt to preserve the quality and/or prolong the quantity of their lives. The average prolongation in survival with chemotherapy compared with best supportive care has not been well described. METHODS: We performed a literature search using PUBMED combined with expert inquiry to identify trials comparing cytotoxic chemotherapy with best supportive care. Twenty-five randomized, controlled clinical trials comparing cytotoxic chemotherapy with best supportive care were identified. Sixteen trials (64%) were in patients with non-small-cell lung cancer (NSCLC). Data were extracted and analyzed. RESULTS: Sufficient data for statistical modeling were available for NSCLC trials. The mean sample size of the NSCLC trials was 175 patients. Response rates in the treatment arms for NSCLC ranged from 7% to 42%. A relationship between response rate and survival was observed for NSCLC. The estimated relationship for NSCLC suggested that each 3.3% increase in response rate correlated, on average, with a 1-week increase in median survival, and each 2% increase in response rate correlated, on average, with a 1% increase in 1-year survival. The mean increase in 1-year survival for trials of agents with at least a 20% response rate in NSCLC was 16%. Formulas are provided to help estimate how a given response rate may effect median and 1-year survival relative to best supportive care alone for NSCLC. CONCLUSION: We found a relationship between response rate and both median and 1-year survival in NSCLC. This information may help oncologists estimate how an NSCLC chemotherapy regimen with a given response rate can, on average, impact survival relative to supportive care alone.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

Can the Gail model be useful in American Indian and Alaska Native populations?

BACKGROUND: Very little is known about breast carcinoma risk factors for American Indian/Alaska Native (AI/AN) women undergoing screening. The Gail model has been a useful tool for predicting the risk of breast carcinoma in several populations. It has not been applied systematically to AI/AN women. METHODS: The current study was a retrospective review of 1458 screening mammograms performed for AI/AN women. The authors applied the Gail model to estimate both absolute risk and relative risk for breast carcinoma for AI/AN women screened in South Dakota, Arizona, and Alaska. RESULTS: The mean age of the women was 52.4 years. The onset of menses was not significantly different than expected. The average age at first birth was 20 years, very few women were nulliparous, and few women were age > 30 years at first live birth. The proportion of women reporting a first- or second-degree relative with breast carcinoma was similar to the proportion in the general population. The results of the model indicated an overall average relative risk that ranged from 1.42 to 2.69 compared with white American women, depending on the model assumptions used. Using a modified Gail model and calculating an imputed absolute risk, the expected incidence of breast carcinoma in this population increased to rates of 170-180 per 100,000 in the next 10 years, a significant increase over the Surveillance, Epidemiology and End Results-derived incidence rates from 1988 to 1992 of 31.6 per 100,000 for AI women in New Mexico and 78.9 per 100,000 for AN women. CONCLUSIONS: The model indicated a likelihood of increasing rates of breast carcinoma in the study population. The data obtained were useful in generating preliminary estimates of breast carcinoma risk in the study population, for which no prospective population survey has been completed. The inherent weaknesses in the current retrospective study indicated the need for a large-scale prospective data collection to confirm these exploratory findings.

Adult↗
PubMed2003

A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma.

BACKGROUND: Recent laboratory and epidemiologic studies have suggested that green tea has antitumor effects in patients with prostate carcinoma. This Phase II trial explored green tea's antineoplastic effects in patients with androgen independent prostate carcinoma. METHODS: This study, which was conducted by the North Central Cancer Treatment Group, evaluated 42 patients who were asymptomatic and had manifested, progressive prostate specific antigen (PSA) elevation with hormone therapy. Continued use of luteinizing hormone-releasing hormone agonist was permitted; however, patients were ineligible if they had received other treatments for their disease in the preceding 4 weeks or if they had received a long-acting antiandrogen therapy in the preceding 6 weeks. Patients were instructed to take 6 grams of green tea per day orally in 6 divided doses. Each dose contained 100 calories and 46 mg of caffeine. Patients were monitored monthly for response and toxicity. RESULTS: Tumor response, defined as a decline >/= 50% in the baseline PSA value, occurred in a single patient, or 2% of the cohort (95% confidence interval, 1-14%). This one response was not sustained beyond 2 months. At the end of the first month, the median change in the PSA value from baseline for the cohort increased by 43%. Green tea toxicity, usually Grade 1 or 2, occurred in 69% of patients and included nausea, emesis, insomnia, fatigue, diarrhea, abdominal pain, and confusion. However, six episodes of Grade 3 toxicity and one episode of Grade 4 toxicity also occurred, with the latter manifesting as severe confusion. CONCLUSIONS: Green tea carries limited antineoplastic activity, as defined by a decline in PSA levels, among patients with androgen independent prostate carcinoma.

Aged↗
PubMed2003

Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting.

This multicenter, randomized, open-label clinical trial was conducted to determine whether the combined use of nicotine patch therapy and a nicotine nasal spray would improve smoking abstinence rates compared to either treatment alone, without behavioral counseling. Data were collected at 15 regional cancer control oncology centers within the North Central Cancer Treatment Group. Of the 1384 smokers randomized to the study, 20% were abstinent from smoking at 6 weeks and 8% were abstinent at 6 months. At 6 weeks, the 7-day point prevalence smoking abstinence rate for the patch alone (21.1%) was superior to the spray (13.6%) but was significantly lower than the rate for combination therapy (27.1%). At 6 months, the 7-day point prevalence abstinence rates were not significantly different among the three groups. Combination nicotine nasal spray and nicotine patches were delivered safely in a nonspecialized outpatient clinical setting and enhanced short-term smoking abstinence rates, but these rates were not sustained at 6 months.

Administration, Cutaneous↗
PubMed2003

Correlates of mammogram density in southwestern Native-American women.

Little is known about the breast cancer risk factors or mammogram characteristics among Native-American women. Southwestern Native-American women have a low risk of breast cancer and a high risk of diabetes. Our purpose was to determine the prevalence of known clinical risk factors for breast cancer and their association with mammogram density in a sample of Southwestern Native-American women undergoing breast cancer screening. A retrospective review was performed of screening mammogram examinations in 455 women. Density was classified by American College of Radiology Breast Imaging Reporting and Data System (BIRADS) density patterns 1 to 4 (fat to dense). Clinical data including patient age, weight, body mass index, parity, lactation, age at first birth, menopause status, hormone replacement therapy, diabetes status, and family history of breast cancer were obtained. Multivariate analyses were performed. Among the entire group, 152 women (33.4%) had diabetes. Patient age (P = 0.0012), weight (P < 0.0001), menopause status (P = 0.0134), estrogen use (P = 0.0311), age at first birth (P = 0.0035), and diabetes (P = 0.0015) were associated with mammogram density. Diabetes was associated with mammogram density in premenopausal women (P = 0.0032) but not in postmenopausal women (P = 0.3178) in stratified analyses. Diabetes, hormone replacement therapy, age, weight, menopause status, parity, and age at first birth were significantly associated with mammogram density. The association of mammogram density with diabetes varied by menopause status and was significant only for premenopausal women.

Adult↗
PubMed2003

Relationship of mammographic parenchymal patterns to breast cancer risk factors and smoking in Alaska Native women.

The purpose is to determine breast cancer risk factors and correlates of mammographic parenchymal patterns among Alaska Native women. A retrospective review was performed of mammograms and mammogram records among 528 sequential screening mammogram examinations performed in Anchorage, Alaska. Mammogram density was classified by American College of Radiology (Breast Imaging Reporting and Data System) density patterns 1-4 (fat-->dense) and by percent density. Clinical data, including risk factors, ethnic group (Indian, Aleut, or Eskimo), and smoking status were obtained. Results were analyzed by univariate and multivariate analyses. Of 528 women, 164 were Indian, 155 were Aleut, and 209 were Eskimo. Mean age at first birth was lower and parity higher compared with published data in white women. Breast cancer risk factors were similar across ethnic groups. In multivariate analysis, patient age, parity, hormone replacement therapy, hysterectomy, and history of biopsy were associated, and smoking was not associated with density scores. Aleut and Indian women were less likely to have high-density mammograms than were Eskimo women (P = 0.0448). No significant differences were found between ethnic group for conventional breast cancer risk factors. Mammogram density was associated with age at screening, parity, hormone replacement therapy, hysterectomy, history of biopsy, and ethnicity but not smoking status. Eskimo women had higher mammogram density than Aleuts or Indians.

Adult↗
PubMed2002

Depomedroxyprogesterone acetate for hot flashes.

To evaluate the efficacy of a long-acting preparation of medroxyprogesterone acetate for hot flash management, 3 men receiving androgen ablation therapy for prostate cancer and 15 women with a history of breast cancer were treated as part of clinical practice with three biweekly intramuscular injections of 500 mg depomedroxyprogesterone. A review of hot flash diaries and patient charts were completed to evaluate the effectiveness and tolerability of these injections for managing hot flashes. Treatment was associated with an approximate 90% decrease in hot flashes (95% CI 82-97%). Daily hot flash frequency decreased from a mean of 10.9 on the first day of treatment (95% CI 8.0-13.8 hot flashes per day) to a mean of 1.1 hot flashes 6 weeks later (95% CI 0.5-1.8 hot flashes) and to a mean of 0.7 hot flashes 12 weeks following therapy initiation (95% CI 0.1-1.2). Improvement in the hot flashes remained for months after discontinuing the injections in many patients. Reported side effects were minimal. This experience suggests that treatment with depomedroxyprogesterone may be an effective and well-tolerated option for the treatment of hot flashes.

Adult↗
PubMedDate not supplied

Venlafaxine for the control of hot flashes: results of a longitudinal continuation study.

PURPOSE/OBJECTIVES: To evaluate the intermediate term efficacy and toxicity of the use of venlafaxine for the control of hot flashes. DESIGN: An open-label continuation phase study following a double-blind, randomized, placebo-controlled clinical trial that tested three doses of venlafaxine for the control of hot flashes. SETTING: North Central Cancer Treatment Group institutions. SAMPLE: 102 postmenopausal women. METHODS: Women could titrate venlafaxine to optimum efficacy while recording daily hot flash counts and weekly toxicity information. MAIN RESEARCH VARIABLES: Hot flash frequency, hot flash score. FINDINGS: The reduction in hot flashes previously reported in the randomized study phase was maintained during the open-label study. Toxicity did not appear to increase over time. CONCLUSIONS: The data from this study provides evidence that venlafaxine has intermediate term efficacy and good tolerability as a treatment for hot flashes. IMPLICATIONS FOR NURSING PRACTICE: Nurses can inform symptomatic women that an effective nonhormonal alternative exists to control their hot flashes.

Anorexia↗
PubMedDate not supplied

Pilot evaluation of citalopram for the relief of hot flashes.

Symptoms associated with premature menopause are a significant problem for women with a history of breast cancer who cannot take hormone replacement therapy. Thus, effective nonhormonal alternatives are needed to manage hot flashes, the most prevalent symptom of menopause. Previous studies have defined that venlafaxine, an anti-depressant, is an effective treatment for such hot flashes. Based on suggestive anecdotal information, we set out to evaluate, in a pilot trial, whether the antidepressant citalopram might be a good nonhormonal treatment option to add to our armamentarium for controlling hot flashes. A prospective pilot study was developed in which patients were studied for 5 weeks, with the first week used to establish a baseline, followed by 4 weeks of treatment with citalopram. During the first week of treatment, 10 mg/day of citalopram was taken while 20 mg/day was taken during each of the following three weeks. Hot-flash diaries were completed daily, symptom diaries and quality-of-life items were completed weekly and the Profile of Mood States was completed at baseline and at week 5. Evaluable patients who completed the study had a mean hot-flash frequency reduction of 58% and a mean hot-flash score reduction of 64% from baseline to week 5. The patients finishing the study also reported decreased anger, tension and depression, as well as improved mood. This pilot trial suggests that citalopram may be an effective non-hormonal treatment for hot flashes in women who can tolerate it.

Affect↗