Role of germ line p53 mutations in aneuploidy and immortalization of dermal fibroblasts from Li-Fraumeni cancer patients

Pedigree analysis of certain families with a high incidence of tumors suggests a genetic predisposition to cancer. Li and Fraumeni described a familial cancer syndrome that is characterized by multiple primary tumors, early age of onset, and marked variation in tumor type. Williams and Strong (1) demonstrated that at least 7% of childhood soft tissue sarcoma patients had family histories that is readily explained by a highly penetrant autosomal dominant gene. To characterize the mechanism for genetic predisposition to many tumor types in these families, we have studied genetic alterations in fibroblasts, a target tissue from patients with the Li-Fraumeni Syndrome (LFS).^ We have observed spontaneous changes in initially normal dermal fibroblasts from LFS patients as they are cultured in vitro. The cells acquire an altered morphology, chromosomal anomalies, and anchorage-independent growth. This aberrant behavior of fibroblasts from LFS patients had never been observed in fibroblasts from normal donors. In addition to these phenotypic alterations, patient fibroblasts spontaneously immortalize by 50 population doublings (pd) in culture; unlike controls that remain normal and senesce by 30-35 (2). At 50 pd, immortal fibroblasts from two patients were found to be susceptible to tumorigenic transformation by an activated T24 H-ras oncogene (3). Approximately 80% of the oncogene expressing transfectants were capable of forming tumors in nude mice within 2-3 weeks. p53 has been previously associated with immortalization of cells in culture and cooperation with ras in transfection assays. Therefore, patients' fibroblast and lymphocyte derived DNA was tested for point mutations in p53. It was shown that LFS patients inherited certain point mutations in one of the two p53 alleles (4). Further studies on the above LFS immortal fibroblasts have demonstrated loss of the remaining p53 allele concomitant with escape from senescence. While the loss of the second allele correlates with immortalization it is not sufficient to transformation by an activated H-ras or N-ras oncogene. These immortal fibroblasts are resistant to tumorigenic transformation by v-abl, v-src, c-neu or v-mos oncogene; implying that additional steps are required in the tumorigenic progression of LFS patients' fibroblasts.^ References. (1) Williams et al., J. Natl. Cancer Inst. 79:1213, 1987. (2) Bischoff et al., Cancer Res. 50:7979, 1990. (3) Bischoff et al., Oncogene 6:183, 1991. (4) Malkin et al., Science 250:1233, 1990. ^

Cancer patients' attitudes toward cancer trials

Background. Accurate measurement of attitudes toward participation in cancer treatment trials (CTs) and cancer prevention trials (CPTs) across varied groups could assist health researchers and educators when addressing attitudinal barriers to participation in these trials. ^ Methods. The Attitudes toward Cancer Trials Scales (ACTS) instrument development was based on a conceptual model developed from research literature, clinical practice experience, and empirical testing of items with a sample of 312 respondents. The ACTS contains two scales, the Cancer Trials (CT) scale (4 components; 18 items) and the Cancer Prevention Trials (CPT) scale (3 components; 16 items). Cronbach's alpha values for the CT and CPT scales, respectively, were 0.86 and 0.89. These two scales along with sociodemographic and cancer trial history variables were distributed in a mail survey of former patients of a large cancer research center. The disproportionate stratified probability sampling procedure yielded 925 usable responses (54% response rate). ^ Results. Prevalence of favorable attitudes toward CTs and CPTs was 66% and 69%, respectively. There were no significant differences in mean scale scores by cancer site or gender, but African Americans had more favorable attitudes toward CTs than European Americans. Multiple regression analysis indicated that older age, lower education level, and prior CT participation history were associated with more favorable attitudes toward CTs. Prior CT participation and prior CPT participation were associated with more favorable attitudes toward CPTs. Results also provided evidence of reliability and construct validity for both scales. ^ Conclusions. Middle age, higher education, and European American ethnicity are associated with less positive attitudes about participating in cancer treatment trials. Availability of a psychometrically sound instrument to measure attitudes may facilitate a better understanding decision making regarding participation in CTs and CPTs. It is this author's intention that the ACTS' scales will be used by other investigators to measure attitudes toward CTs and CPTs in various groups of persons, and that the many issues regarding participation in trials might become more explicit. ^

A quality of life subscale for terminally ill cancer patients

A subscale was developed to assess the quality of life of cancer patients with a life expectancy of six months or less. Phase I of this study identified the major concerns of 74 terminally ill cancer patients (19 with breast cancer, 19 with lung cancer, 18 with colorectal cancer, 9 with renal cell cancer, 9 with prostate cancer), 39 family caregivers, and 20 health care professionals. Patients interviewed were being treated at the University of Texas M. D. Anderson Cancer Center or at the Hospice at the Texas Medical Center in Houston. In Phase II, 120 patients (30 with breast cancer, 30 with lung cancer, 30 with colorectal cancer, 15 with prostate cancer, and 15 with renal cell cancer) rated the importance of these concerns for quality of life. Items retained for the subscale were rated as "extremely important" or "very important" by at least 60% of the sample and were reported as being applicable by at least two-thirds of the sample. The 61 concerns that were identified were formatted as a questionnaire for Phase III. In Phase III, 356 patients (89 with breast cancer, 88 with lung cancer, 88 with colorectal cancer, 44 with prostate cancer, and 47 with renal cell cancer) were interviewed to determine the subscale's reliability and sensitivity to change in clinical status. Both factor analysis and item response theory supported the inclusion of the same 35 items for the subscale. Internal consistency reliability was moderate to high for the subscale's domains: spiritual (0.87), existential (0.76), medical care (0.68), symptoms (0.67), social/family (0.66), and emotional (0.61). Test-retest correlation coefficients also were high for the domains: social/family (0.86), emotional (0.83), medical care (0.83), spiritual (0.75), existential (0.75), and symptoms (0.81).^ In addition, concurrent validity was supported by the high correlation between the subscale's symptom domain and symptom items from the European Organization for Research and Treatment of Cancer (EORTC) scale (r = 0.74). Patients' functional status was assessed with the Eastern Cooperative Oncology Group (ECOG) Performance status rating. When ECOG categories were compared to subscale domains, patients who scored lower in functional status had lower scores in the spiritual, existential, social/family, and emotional domains. Patients who scored lower in physical well-being had higher scores in the symptom domain. Patient scores in the medical care domain were similar for each ECOG category. The results of this study support the subscale's use in assessing quality of life and the outcomes of palliative treatment for cancer patients in their last six months of life. ^

Risk, outcomes, and cost of emergency center visits in cancer patients

Cancer is a chronic disease that often necessitates recurrent hospitalizations, a costly pattern of medical care utilization. In chronically ill patients, most readmissions are for treatment of the same condition that caused the preceding hospitalization. There is concern that rather than reducing costs, earlier discharge may shift costs from the initial hospitalization to emergency center visits. ^ This is the first descriptive study to measure the incidence of emergency center visits (ECVs) after hospitalization at The University of M. D. Anderson Cancer Center (UTMDACC), to identify the risk factors for and outcomes of these ECVs, and to compare 30-day all-cause mortality and costs for episodes of care with and without ECVs. ^ We identified all hospitalizations at UTMDACC with admission dates from September 1, 1993 through August 31, 1997 which met inclusion criteria. Data were electronically obtained primarily from UTMDACC's institutional database. Demographic factors, clinical factors, duration of the index hospitalization, method of payment for care, and year of hospitalization study were variables determined for each hospitalization. ^ The overall incidence of ECVs was 18%. Forty-five percent of ECVs resulted in hospital readmission (8% of all hospitalizations). In 1% of ECVs the patient died in the emergency center, and for the remaining 54% of ECVs the patient was discharged home. Risk factors for ECVs were marital status, type of index hospitalization, cancer type, and duration of the index hospitalization. The overall 30-day all-cause mortality rate was 8.6% for hospitalizations with an ECV and 5.3% for those without an ECV. In all subgroups, the 30-day all-cause mortality rate was higher for groups with ECVs than for those without ECVs. The most important factor increasing cost was having an ECV. In all patient subgroups, the cost per episode of care with an ECV was at least 1.9 times the cost per episode without an ECV. ^ The higher costs and poorer outcomes of episodes of care with ECVs and hospital readmissions suggest that interventions to avoid these ECVs or mitigate their costs are needed. Further research is needed to improve understanding of the methodological issues involved in relation to health care issues for cancer patients. ^

Comprehensive environmental study in high risk areas for cancer patients comparing air and water Aspergillus species samples

Background. Nosocomial invasive aspergillosis (a highly fatal disease) is an increasing problem for immunocompromised patients. Aspergillus spp. can be transmitted via air (most commonly) and by water. ^ The hypothesis for this prospective study was that there is an association between patient occupancy, housekeeping practices, patients, visitors, and Aspergillus spp. loading. Rooms were sampled as not terminally cleaned (dirty) and terminally cleaned (clean). The secondary hypothesis was that Aspergillus spp. positive samples collected from more than one sampling location within the same patient room represent the same isolate. ^ Methods. Between April and October 2004, 2873 environmental samples (713 air, 607 water, 1256 surface and 297 spore traps) were collected in and around 209 “clean” and “dirty” patient rooms in a large cancer center hospital. Water sources included aerosolized water from patient room showerheads, sinks, drains, and toilets. Bioaerosol samples were from the patient room and from the running shower, flushing toilet, and outside the building. The surface samples included sink and shower drains, showerheads, and air grills. Aspergillus spp. positive samples were also sent for PCR, molecular typing (n = 89). ^ Results. All water samples were negative for Aspergillus spp. There were a total of 130 positive culturable samples (5.1%). The predominant species found was Aspergillus niger. Of the positive culturable samples, 106 (14.9%) were air and 24 (3.8%) were surface. There were 147 spore trap samples, and 49.5% were positive for Aspergillus/Penicillum spp. Of the culturable positive samples sent for PCR, 16 were indistinguishable matches. There was no significant relationship between air and water samples and positive samples from the same room. ^ Conclusion. Primarily patients, visitors and staff bring the Aspergillus spp. into the hospital. The high number of A. niger samples suggests the spores are entering the hospital from outdoors. Eliminating the materials brought to the patient floors from the outside, requiring employees, staff, and visitors to wear cover up over their street clothes, and improved cleaning procedures could further reduce positive samples. Mold strains change frequently; it is probably more significant to understand pathogenicity of viable spores than to commit resources on molecular strain testing on environmental samples alone. ^

The role of smoking status on postoperative complications and survival in lung cancer patients presenting to M.D. Anderson Cancer Center

It is estimated that 50% of all lung cancer patients continue to smoke after diagnosis. Many of these lung cancer patients who are current smokers often experience tremendous guilt and responsibility for their disease, and feel it might be too late for them to quit smoking. In addition, many oncologists may be heard to say that it is 'too late', 'it doesn't matter', 'it is too difficult', 'it is too stressful' for their patients to stop smoking, or they never identify the smoking status of the patient. Many oncologists feel unprepared to address smoking cessation as part of their clinical practice. In reality, physicians can have tremendous effects on motivating patients, particularly when patients are initially being diagnosed with cancer. More information is needed to convince patients to quit smoking and to encourage clinicians to assist patients with their smoking cessation. ^ In this current study, smoking status at time of lung cancer diagnosis was assessed to examine its impact on complications and survival, after exploring the reliability of smoking data that is self-reported. Logistic Regression was used to determine the risks of smoking prior to lung resection. In addition, survival analysis was performed to examine the impact of smoking on survival. ^ The reliability of how patients report their smoking status was high, but there was some discordance between current smokers and recent quitters. In addition, we found that cigarette pack-year history and duration of smoking cessation were directly related to the rate of a pulmonary complication. In regards to survival, we found that current smoking at time of lung cancer diagnosis was an independent predictor of early stage lung cancer. This evidence supports the idea that it is "never too late" for patients to quit smoking and health care providers should incorporate smoking status regularly into their clinical practice.^

Response to chemotherapy, recurrence and survival in advanced-stage ovarian, fallopian tube and primary peritoneal cancer patients with non-Ashkenazi Jewish BRCA mutations, compared to those without

Objectives. Previous studies have shown a survival advantage in ovarian cancer patients with Ashkenazi-Jewish (AJ) BRCA founder mutations, compared to sporadic ovarian cancer patients. The purpose of this study was to determine if this association exists in ovarian cancer patients with non-Ashkenazi Jewish BRCA mutations. In addition, we sought to account for possible "survival bias" by minimizing any lead time that may exist between diagnosis and genetic testing. ^ Methods. Patients with stage III/IV ovarian, fallopian tube, or primary peritoneal cancer and a non-Ashkenazi Jewish BRCA1 or 2 mutation, seen for genetic testing January 1996-July 2007, were identified from genetics and institutional databases. Medical records were reviewed for clinical factors, including response to initial chemotherapy. Patients with sporadic (non-hereditary) ovarian, fallopian tube, or primary peritoneal cancer, without family history of breast or ovarian cancer, were compared to similar cases, matched by age, stage, year of diagnosis, and vital status at time interval to BRCA testing. When possible, 2 sporadic patients were matched to each BRCA patient. An additional group of unmatched, sporadic ovarian, fallopian tube and primary peritoneal cancer patients was included for a separate analysis. Progression-free (PFS) & overall survival (OS) were calculated by the Kaplan-Meier method. Multivariate Cox proportional hazards models were calculated for variables of interest. Matched pairs were treated as clusters. Stratified log rank test was used to calculate survival data for matched pairs using paired event times. Fisher's exact test, chi-square, and univariate logistic regression were also used for analysis. ^ Results. Forty five advanced-stage ovarian, fallopian tube and primary peritoneal cancer patients with non-Ashkenazi Jewish (non-AJ) BRCA mutations, 86 sporadic-matched and 414 sporadic-unmatched patients were analyzed. Compared to the sporadic-matched and sporadic-unmatched ovarian cancer patients, non-AJ BRCA mutation carriers had longer PFS (17.9 & 13.8 mos. vs. 32.0 mos., HR 1.76 [95% CI 1.13–2.75] & 2.61 [95% CI 1.70–4.00]). In relation to the sporadic- unmatched patients, non-AJ BRCA patients had greater odds of complete response to initial chemotherapy (OR 2.25 [95% CI 1.17–5.41]) and improved OS (37.6 mos. vs. 101.4 mos., HR 2.64 [95% CI 1.49–4.67]). ^ Conclusions. This study demonstrates a significant survival advantage in advanced-stage ovarian cancer patients with non-AJ BRCA mutations, confirming the previous studies in the Jewish population. Our efforts to account for "survival bias," by matching, will continue with collaborative studies. ^

Role of stress myocardial perfusion scan in pre-operative evaluation of cancer patients undergoing non-cardiac surgery

Background. Cardiac risk assessment in cancer patients has not extensively been studied. We evaluated the role of stress myocardial perfusion imaging (MPI) in predicting cardiovascular outcomes in cancer patients undergoing non-cardiac surgery. ^ Methods. A retrospective chart review was performed on 507 patients who had a MPI from 01/2002 - 03/2003 and underwent non-cardiac surgery. Median follow-up duration was 1.5 years. Cox proportional hazard model was used to determine the time-to-first event. End points included total cardiac events (cardiac death, myocardial infarction (MI) and coronary revascularization), cardiac death, and all cause mortality. ^ Results. Of all 507 MPI studies 146 (29%) were abnormal. There were significant differences in risk factors between normal and abnormal MPI groups. Mean age was 66±11 years, with 60% males and a median follow-up duration of 1.8 years (25th quartile=0.8 years, 75th quartile=2.2 years). The majority of patients had an adenosine stress study (53%), with fewer exercise (28%) and dobutamine stress (16%) studies. In the total group there were 39 total cardiac events, 31 cardiac deaths, and 223 all cause mortality events during the study. Univariate predictors of total cardiac events included CAD (p=0.005), previous MI (p=0.005), use of beta blockers (p=0.002), and not receiving chemotherapy (p=0.012). Similarly, the univariate predictors of cardiac death included previous MI (p=0.019) and use of beta blockers (p=0.003). In the multivariate model for total cardiac events, age at surgery (HR 1.04, p=0.030), use of beta blockers (HR 2.46; p=0.011), dobutamine MPI (HR 3.08; p=0.018) and low EF (HR 0.97; p=0.02) were significant predictors of worse outcomes. In the multivariate model for predictors of cardiac death, beta blocker use (HR=2.74; p=0.017) and low EF (HR=0.95; p<0.003) were predictors of cardiac death. The only univariate MPI predictor of total cardiac events was scar severity (p=0.005). While MPI predictors of cardiac death were scar severity (p= 0.001) and ischemia severity (p=0.02). ^ Conclusions. Stress MPI is a useful tool in predicting long term outcomes in cancer patients undergoing surgery. Ejection fraction and severity of myocardial scar are important factors determining long term outcomes in this group.^

Racial/ethnic differences in factors influencing screening and treatment among prostate cancer patients

Background. Racial/ethnic differences have been found in various aspects of cancer care. But a limited number of studies have examined the racial/ethnic differences in predictors of prostate-specific antigen (PSA) screening in a group of prostate cancer patients and have attempted to identify the racial/ethnic differences in treatment discussions, treatment choice and treatment received for organ-confined localized prostate cancer (PCa) among three major racial/ethnic groups of the USA. This study was conducted to redress this lack of information. ^ Methods. This study was conducted on a group of 935 prostate cancer patients representing all three major race/ethnic groups (Whites, African Americans and Hispanics) who were treated at various medical institutes of the Texas Medical Center, Houston between 1996 and 2004 to identify the racial/ethnic differences in predictors of PSA screening. A subset of 640 patients who had organ-confined localized prostate cancer was selected to examine the racial/ethnic differences in treatment discussions, treatment choice and treatment received for their localized prostate cancer. They were interviewed by trained research interviewers of MD Anderson Cancer Center using a validated structured questionnaire. ^ Results. The results showed that African American (54.4%) and Hispanic patients (42.3%) were significantly less likely (p=0.004 and p<.001, respectively) than White patients (63.2%) to report having had PSA screening before their prostate-cancer diagnosis. Among Whites, only education and annual check-ups predicted the use of PSA screening, whereas in African Americans two more additional factors, marital status and bode-mass index (BMI), significantly predicted PSA screening. Among Hispanics, like two other groups, education and annual check-ups also appeared as a significant predictor of PSA screening. ^ Results from multivariable logistic regression showed that African American patients were 15% less likely (OR=0.85, 95% CI=0.61-1.17, p=0.32) and Hispanics patients were 40% less likely (OR=0.60, 95% CI=0.41-0.87, p=0.008) to undergo PSA screening than Whites after adjusting for education and age at diagnosis for African Americans, and for education, annual check-ups and age at diagnosis for Hispanics. ^ This study revealed that health professionals were less likely to discuss surgery (79.9% vs. 93.2%) and watchful waiting (27.9% vs. 43.9%) with Hispanics compared to Whites. African Americans were more likely to choose (35.1% vs. 27.7%) and receive radiation therapy (38.3% vs.31.4%) than Whites. A comparison of concordance between treatment choice and treatment received showed that the highest concordance was found for watchful waiting and radiation therapy among African Americans (100% and 85.9%, respectively) whereas the highest concordance (96.9%) was found for surgery among Hispanics. ^ Conclusions. In this multiethnic study, the rates of PSA screening and its potential predictors varied by racial/ethnic groups. Substantial racial/ethnic variations were also found in treatment discussion, but the differences were not evident for treatment choice and treatment received. Health-education programs and culturally appropriate educational outreach efforts, especially targeted for high-risk groups, are needed to reduce these disparities. In the current climate of uncertainty about the benefits of PSA screening, or the benefit of one treatment over others, men should have access to information and services regardless of race/ethnicity so that they can make informed decisions. Further in-depth studies are needed in other settings to confirm these findings with the goal of developing an intervention to address these concerns. ^

Theory of uncertainty in illness in patients with cancer of unknown primary origin: Structure providers as antecedents of uncertainty in a population of cancer patients with an unknown primary diagnosis

Uncertainty has been found to be a major component of the cancer experience and can dramatically affect psychosocial adaptation and outcomes of a patient's disease state (McCormick, 2002). Patients with a diagnosis of Carcinoma of Unknown Primary (CUP) may experience higher levels of uncertainty due to the unpredictability of current and future symptoms, limited treatment options and an undetermined life expectancy. To date, only one study has touched upon uncertainty and its' effects on those with CUP but no information exists concerning the effects of uncertainty regarding diagnosis and treatment on the distress level and psychosocial adjustment of this population (Parker & Lenzi, 2003). ^ Mishel's Uncertainty in Illness Theory (1984) proposes that uncertainty is preceded by three variables, one of which being Structure Providers. Structure Providers include credible authority, the degree of trust and confidence the patient has with their doctor, education and social support. It was the goal of this study to examine the relationship between uncertainty and Structure Providers to support the following hypotheses: (1) There will be a negative association between credible authority and uncertainty, (2) There will be a negative association between education level and uncertainty, and (3) There will be a negative association between social support and uncertainty. ^ This cross-sectional analysis utilized data from 219 patients following their initial consultation with their oncologist. Data included the Mishel Uncertainty in Illness Scale (MUIS) which was used to determine patients' uncertainty levels, the Medical Outcomes Study-Social Support Scale (MOSS-SSS) to assess patients, levels of social support, the Patient Satisfaction Questionnaire (PSQ-18) and the Cancer Diagnostic Interview Scale (CDIS) to measure credible authority and general demographic information to assess age, education, marital status and ethnicity. ^ In this study we found that uncertainty levels were generally higher in this sample as compared to other types of cancer populations. And while our results seemed to support most of our hypothesis, we were only able to show significant associations between two. The analyses indicated that credible authority measured by both the CDIS and the PSQ was a significant predictor of uncertainty as was social support measured by the MOSS-SS. Education has shown to have an inconsistent pattern of effect in relation to uncertainty and in the current study there was not enough data to significantly support our hypothesis. ^ The results of this study generally support Mishel's Theory of Uncertainty in Illness and highlight the importance of taking into consideration patients, psychosocial factors as well as employing proper communication practices between physicians and their patients.^

Treatment discontinuation among breast, colorectal, and prostate cancer patients in Alabama

Introduction. Cancer registries provide information about treatment initiation but not the full course of treatment. In an effort to identify patient reported reasons for discontinuing cancer treatment, patients with prostate, breast, and colorectal cancer were identified from Alabama State Cancer Registry (ASCR) -Alabama Medicare linked database for interview. This study has two specific aims: (1) determine whether the ASCR-Medicare database accurately reflects patients’ treatment experiences in terms of whether they started and completed treatment when compared to patient self-report and (2) determine which patient demographic and health care system factors are related to treatment completion as defined by patient self-report. ^ Methods. The ASCR-Medicare claims dataset supplemented patient interview responses to identify treatment initiation and completion among prostate, breast, and colorectal cancer patients in Alabama from 1999-2003. Kappa statistic was used to test for concordance of treatment initiation and completion between patient self-report and Medicare claims data. Patients who reported not completing treatment were asked questions to ascertain reasons for treatment discontinuation. Logistic regression models were constructed to explore the association of patient and tumor characteristics with discontinuation of radiation and chemotherapy. ^ Results. Overall, there was a fair agreement across all cancer sites about whether one had surgery (Kappa=.382). There was fair agreement between self-report and Medicare claims data for starting radiation treatment (Kappa=.278). For starting chemotherapy there was moderate agreement (Kappa=.414). There was no agreement for completing treatment for radiation and chemotherapy between the self-report and claims data. Patients most often reported doctor’s recommendation (40% for radiation treatment and 21.4% for chemotherapy) and side effects (30% for radiation treatment and 42.8% for chemotherapy) for discontinuing treatment. Females were less likely to complete radiation than males (OR=.24, 95% CI=.11–.50). Stage I patients were more likely to drop radiation treatment than stage III patients (OR=3.34, 95% CI=1.12–9.95). Younger patients were more likely to discontinue chemotherapy than older patients (OR=2.84 95%, CI=1.08–7.69) and breast cancer patients were less likely to discontinue chemotherapy than colorectal patients (OR=.13, 95% CI=.04–.46). ^ Conclusion. This study reveals that patients recall starting treatment more accurately than completing treatment and that there are several demographic and tumor characteristics that influence treatment discontinuation. Providing patients with treatment summaries and survivorship plans can help patients their follow-up care when there are gaps in treatment recall and discontinuation of treatment.^

Hypogonadism in male cancer patients: A cross-sectional study

Introduction. Cancer is the second most common cause of death in the USA (2). Studies have shown a coexistence of cancer and hypogonadism (9,31,13). The majority of patients with cancer develop cachexia, which cannot be solely explained by anorexia seen in these patients. Testosterone is a male sex hormone which is known to increase muscle mass and strength, maintain cancellous bone mass, and increase cortical bone mass, in addition to improving libido, sexual desire, and fantasy (14). If a high prevalence of hypogonadism is detected in male cancer patients, and a significant difference exists in testosterone levels in cancer patients with cachexia versus those without cachexia, testosterone may be administered in future randomized trials to help alleviate cachexia. Study group and design The study group consisted of male cancer patients and non-cancer controls aged between 40 and 70 years. The primary study design was cross-sectional with a sample size of 135. The present data analysis is done on a subset convenience sample of 72 patients recruited between November 2006 and January 2010. ^ Methods. Patients aged 40-70 years with or without a diagnosis of cancer were recruited into the study. All patients with a BMI over 35, significant edema, non-melanomatous skin cancer, current alcohol or illicit drug abuse, concomitant usage of medications interfering with gonadal axis, and anabolic agents, patients on tube feeds or parenteral nutrition within 3 months prior to enrollment were excluded from the study. The study was approved by the Institutional Review Board of Baylor College of Medicine and is being conducted at the Michael E. DeBakey Veterans Affairs Medical Center at Houston. My thesis is a pilot data analysis that employs a smaller subset convenience sample of 72 patients determined by using the data available for the 72 patients (of the intended sample of 135 patients) recruited between November 2006 and January 2010. The primary aim of this analysis is to compare the proportion of patients with hypogonadism in the male cancer and non-cancer control groups, and to evaluate if a significant difference exists with respect to testosterone levels in male cancer patients with cachexia versus those without cachexia. The procedures of the study relevant to the current data analysis included blood collection to measure levels of testosterone and measurement of body weight to categorize cancer patients into cancer cachexia and cancer non-cachexia sub-groups. ^ Results. After logarithmic transformation of data of cancer and control groups, the unpaired t test with unequal variances was done. The proportion of patients with hypogonadism in the male cancer and non-cancer control groups was 47.5% and 22.7% with a Pearson chi2 statistic of 1.6036 and a p value of 0.205. Comparing the mean calculated Bioavailable testosterone in male cancer patients and non-cancer controls resulted in a t statistic of 21.83 and a p value less than 0.001. When the cancer group alone was taken, the mean free testosterone, calculated bioavailable testosterone and total testosterone levels in the cancer non-cachexia sub-group were 3.93, 5.09, 103.51 respectively and in the cancer cachexia sub-group were 3.58, 4.17, 84.08 respectively. The unpaired t test with equal variances showed that the two sub-groups had p values of 0.2015, 0.1842, and 0.4894 with respect to calculated bioavailable testosterone, free testosterone, and total testosterone respectively. ^ Conclusions. The small sample size of this exploratory study, resulting in a small power, does not allow us to draw definitive conclusions. For the given sub-sample, the proportion of patients with hypogonadism in the cancer group was not significantly different from that of patients with hypogonadism in the control group. Inferences on prevalence of hypogonadism in male cancer patients could not be made in this paper as the sub-sample is small and therefore not representative of the general population. However, there was a statistically significant difference in calculated Bioavailable testosterone levels in male cancer patients versus non-cancer controls. Analysis of cachectic and non-cachectic patients within the male cancer group showed no significant difference in testosterone levels (total, free, and calculated bioavailable testosterone) between both sub-groups. However, to re-iterate, this study is exploratory and the results may change once the complete dataset is obtained and analyzed. It however serves as a good template to guide further research and analysis.^

The effect of yoga on cardiovascular health as measured by heart rate variability in a sample of breast cancer patients

The study is a three-armed randomized controlled trial comparing values for heart rate variability (HRV), a measure of cardiovascular health, throughout a yoga intervention of breast cancer patients undergoing radiotherapy. Patients attended either a yoga (n=45), stretch, (n=46), or control (n=42) condition 3 times per week for 6 weeks of radiation. Electrocardiograms (ECGs) were conducted on each participant to provide the values necessary for HRV analysis. Analyses focused on examining scores for those participants with HRV baseline values considered to be below the cutoff point for healthy HRV levels, defined by the authors as below the cutpoint of 68 ms. From the entire sample of 133 with available baselines, 26 yogis, 26 stretchers, and 23 controls were determined to be “pathologic” in terms of HRV, and selected for follow-up analysis at 3 weeks and then again at 6 weeks. Though no statistically significant differences were found between either group means at each timepoint or group change score means, the yoga group had consistently higher mean score and mean change scores. These findings are suggestive and indicate the need to refine the use of ECGs and HRV analysis programs to more accurately and comprehensively assess the effects of yoga on cardiovascular health in cancer patients.^

Understanding treatment-related symptoms, symptom management techniques, and symptom management self-efficacy in a sample of non-muscle invasive bladder cancer patients

The current literature available on bladder cancer symptom management from the perspective of the patients themselves is limited. There is also limited psychosocial research specific to bladder cancer patients and no previous studies have developed and validated measures for bladder cancer patients’ symptom management self-efficacy. The purpose of this study was to investigate non-muscle invasive bladder cancer patients’ health related quality of life through two main study objectives: (1) to describe the treatment related symptoms, reported effectiveness of symptom-management techniques, and the advice a sample of non-muscle invasive bladder cancer patients would convey to physicians and future patients; and (2) to evaluate Lepore’s symptom management self-efficacy measure on a sample of non-muscle invasive bladder cancer patients. Methods. A total of twelve (n=12) non-muscle invasive bladder cancer patients participated in an in-depth interview and a sample of 46 (n=4) non-muscle invasive bladder cancer patients participated in the symptom-management self-efficacy survey. Results. A total of five symptom categories emerged for the participants’ 59 reported symptoms. Four symptom management categories emerged out of the 71 reported techniques. A total of 62% of the participants’ treatment related symptom-management techniques were reported as effective in managing their treatment-related symptoms. Five advice categories emerged out of the in-depth interviews: service delivery; medical advice; physician-patient communication; encouragement; and no advice. An exploratory factor analysis indicated a single-factor structure for the total population and a multiple factor structure for three subgroups: all males, married males, and all married participants. Conclusion. These findings can inform physicians and patients of effective symptom-management techniques thus improving patients’ health-related quality of life. The advice these patients’ impart can improve service-delivery and patient education.^