Dilator Use After Vaginal Brachytherapy for Endometrial Cancer: A Randomized Feasibility and Adherence Study.

BACKGROUND: Vaginal brachytherapy, a common treatment of endometrial cancer, is associated with high rates of vaginal stenosis. Recommendations for vaginal dilator use to minimize stenosis generally include 3 times per week for approximately 10 minutes per use. However, adherence rates range widely and are generally well less than 50%. OBJECTIVES: The aims of this study were to assess feasibility of recruitment to a study of dilator use and test a theoretically driven enhanced educational program (EEP) to increase adherence. METHODS: Eligibility included women treated with postoperative vaginal brachytherapy for stage I to IIIc endometrial cancer. Patients were randomized to either nurse-delivered standard institutional instruction or EEP. RESULTS: Of eligible patients, 76% consented, 42 were randomized, and 69% completed the 6-month assessment. Mean age was 58.2 years; 48% were sexually active. There was no difference in adherence between arms. Overall, 20% and 8.3% were adherent to the prescribed use of 3 times per week, and 64% and 16% were adherent to use at least once per week at 6 weeks and 6 months, respectively. Adherence was greater among those motivated by vaginal health and having lower body mass index. Nonadherence was significantly higher among those who are college educated, in the EEP group, and with higher weight. CONCLUSIONS: Feasibility of recruitment into a study of vaginal dilator use was high. Adherence was low, and there was no difference between groups. Adherence to vaginal dilator use requires novel interventions to test. IMPLICATIONS FOR PRACTICE: Nursing education that includes how dilators may maintain vaginal health may improve use because it was a motivator for adherence in this study.

Circadian rhythm of hot flashes and activity levels among prostate cancer patients on androgen deprivation therapy.

OBJECTIVE: Altered circadian rhythms have been identified in untreated prostate cancer patients. Findings of restored rhythmicity following cancer treatment may have relevance for cancer control and symptom management. This study assessed and compared the cyclic patterns of hot flashes and activity levels in treated prostate cancer patients. METHODS: Data were collected during two 24-h periods among 47 prostate patients undergoing androgen deprivation therapy (ADT). Hot flashes were detected objectively through sternal skin conductance and by patients via electronic event marking. Activity levels were recorded on a wrist actigraphy device. RESULTS: The mean frequency of objectively measured and patient-reported hot flashes was 13.6 (SD = 14.3) and 12.6 (SD = 9.6), respectively. There were significant 24-h circadian rhythms of both hot flashes and activity levels. The peak of the rhythms occurred in early afternoon. There was no significant cross correlation between hot flashes and activity levels. CONCLUSIONS: The acrophases of hot flashes and elevated activity levels in this study may represent a normalisation of circadian rhythms following ADT, pointing to the need for more research, including controlled, prospective chronobiologic studies. Future research may have important implications for the survival of prostate cancer patients and the identification of new and safe hot flash treatments.

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.

Hot flashes during pregnancy: a comparative study.

OBJECTIVE: To conduct a preliminary study assessing the association of hot flashes with pregnancy. STUDY DESIGN: 268 pregnant and non-pregnant women matched on age and race completed a written questionnaire on sociodemographic and clinical information and the experiences of hot flashes. Binary logistic regressions were used to determine predictors of hot flashes. RESULTS: While controlling for significant bivariate associations, pregnant women were more likely to report hot flashes than non-pregnant women (odds ratio 5.22; confidence interval 2.75-9.89; p<0.001). Hot flashes during pregnancy typically first occurred before the third trimester and were experienced on a weekly basis. Most pregnant women reported that their hot flashes were not severe or bothersome. CONCLUSIONS: Findings suggest that hot flashes are common during pregnancy. Studies of hot flashes during pregnancy may further elucidate the causal mechanisms of hot flashes in other populations.

Comparison of objective and patient-reported hot flash measures in men with prostate cancer.

Hot flashes are one of the bothersome symptoms frequently experienced after endocrine treatments for breast and prostate cancers. Many studies have evaluated interventions for hot flashes, but results are obscured by methodologic limitations. We compared the performance of three techniques to measure hot flashes over 48 hours among 47 patients with prostate cancer undergoing androgen deprivation therapy to determine the feasibility and accuracy of each measure. Sternal skin conductance, electronic event marking, and twice daily diaries identified 478, 410, and 285 hot flashes, respectively. Diaries produced the lowest hourly hot flash rate (M = 0.17), which was significantly different from the rates of the objective profile (M = 0.28) and event marks (M = 0.23).The sensitivity and positive predictive value of the three measures demonstrated that the diaries underperformed, but these values did not exceed moderate levels for any measure (% = 28-59). Study results suggest the combined use of sternal skin conductance and event marking for the measurement of hot flash frequency in pathophysiologic studies and clinical trials with prostate cancer patients. Conversely, the use of retrospective diaries may be adequate for clinical practice to determine clinically significant changes in salient events.

Increases in core body temperature precede hot flashes in a prostate cancer patient.

OBJECTIVE: An effective and safe alternative treatment to hormone replacement therapy for hot flashes is needed for cancer patients. Interventions targeting the triggering mechanisms of hot flashes hold promise. Increases in core body temperature are a precursor of most hot flashes in women, and similar findings in prostate cancer patients undergoing androgen deprivation therapy would support further research in this area. We present preliminary findings of physiological changes in a prostate cancer patient with frequent hot flashes. METHODS: Physiological changes in sternal skin conductance, heart rate, and core body temperature were continuously measured during two 3.5 h laboratory sessions. Perceived characteristics of hot flashes were recorded in a diary. RESULTS: Five hot flashes were reported during laboratory sessions. Severity and bother ratings were low. All hot flashes were accompanied by large increases in sternal skin conductance and moderate increases in heart rate. Core body temperature increased 0.11-0.32 degrees C prior to and fell 0.23-0.44 degrees C following the peak increase in skin conductance. CONCLUSIONS: This case study suggests that hot flashes in men may be preceded by increases in core body temperature. Identification of behavioral factors that raise core body temperature may lead to specific treatment strategies to reduce the frequency of hot flashes.

Hot flashes and panic attacks: a comparison of symptomatology, neurobiology, treatment, and a role for cognition.

Despite decades of research, the causal mechanisms of hot flashes are not adequately understood, and a biopsychosocial perspective on hot flashes remains underdeveloped. This article explores overlooked parallels between hot flashes and panic attacks within 5 areas: course and symptomatology, physiological indicators, neurocircuitry and biochemical mechanisms, pharmacotherapy, and psychological treatment, noting both similarities and important differences between the 2 events. An integrative conceptual model is presented that identifies key ways in which psychological factors may influence the experience of hot flashes, with clinical implications and areas of future research. This model yields readily testable hypotheses and may provide a template for exploring the role of cognition in the frequency and severity of hot flashes and, in turn, a basis for the development of nonpharmacological treatments.

Validation of sternal skin conductance for detection of hot flashes in prostate cancer survivors.

The gold standard for objectively measuring hot flashes in women is an increased sternal skin conductance level (SCL), but validation studies in prostate cancer patients are lacking. In the laboratory, an SCL increase of > or = 1.78 micro-mho in 45 s had a sensitivity of 68% and a positive predictive value of 100% in detecting self-reported hot flashes among prostate cancer patients. Outside the laboratory, 71% of the objective markers of hot flashes were accompanied by a subjective report of a hot flash, and 65% of subjective reports occurred in the absence of an objective criterion. This study demonstrates that sternal skin conductance can be used to detect hot flashes in men in a manner analogous to its utilization among women. Such use would improve outcome analysis of treatment studies.

Prevalence of childhood sexual abuse and physical trauma in an HIV-positive sample from the deep south.

We examined prevalence and predictors of trauma among HIV-infected persons in the Deep South using data from the Coping with HIV/AIDS in the Southeast (CHASE) study. Over 50% of CHASE participants were abused during their lives, with approximately 30% experiencing abuse before age 13, regardless of gender. Caregiver characteristics were associated with childhood abuse. Abuse is related to increases in high-HIV-risk activities. The findings help explain why people engage in such high-risk activities and can provide guidance in designing improved care and prevention messages.

A brief mental health and substance abuse screener for persons with HIV.

Mental illness and substance abuse are common among HIV-infected individuals and are associated with negative outcomes, including poor medication adherence. Therefore, quick and effective methods for detecting these co-occurring disorders are necessary for health care practitioners. This article reports on the creation and preliminary testing of a brief screening tool, the Substance Abuse and Mental Illness Symptoms Screener (SAMISS). The 13-item screener was developed primarily from existing scales and administered to HIV-infected individuals receiving care at infectious diseases clinics in the Southeast. To assess the validity of the SAMISS, a subset of those who screened positive for both mental illness symptoms and substance use problems (n = 207) were administered the Structured Clinical Interview for DSMIV Disorders (SCID). The positive predictive value of the screener in comparison to the SCID was 98.6% for mental disorders and 98.6% for substance use disorders. The agreement between specific screener symptoms and their corresponding SCID diagnoses was relatively high for alcohol dependence (kappa = 0.50, p < 0.001), drug dependence (kappa = 0.30, p < 0.001), and drug abuse (kappa = 0.42, p <0.001). The finding that the screener is highly predictive of having a general mental disorder and substance use disorder among those screening positive for mental illness symptoms and substance use problems, as well as its brevity and ease of administration, make it a useful tool to detect symptoms of co-occurring disorders so that patients can be referred to mental health and substance abuse specialists. The screener is not a diagnostic instrument and has limited value in predicting specific psychiatric diagnoses.