Use of Placebo Pills Before Treatment Initiation in Youth with HIV: Are They Ready?

Highly active antiretroviral therapy (HAART) nonadherence is related to negative health outcomes and is well-documented in adolescents and young adults (AYAs) with behaviorally acquired HIV. Few studies describe methods to improve adherence in this population. This retrospective study describes placebo pill trial use (ie, pills with inert substance prescribed to practice taking HAART) in AYAs initiating HAART and its relation to disease outcomes. Sixty-two AYAs initiated HAART during the review period. Disease outcomes during the first year of standard clinical care were abstracted from medical records. In all, 72.6% of participants received ≥1 pill trial and 27.4% received ≥2 trials. Placebo trial use was not independently related to adherence post-HAART initiation. "Prescription" of a second trial was related to less optimal disease status over the first 6 months of treatment. Placebo trials have the potential to inform clinical care, aid in identifying AYAs at risk for nonadherence, and may provide a novel intervention strategy before/after HAART initiation.

Excessive decline from premorbid functioning: detecting performance invalidity with the WAIS-IV and demographic predictions.

OBJECTIVE: Excessive Decline from Premorbid Functioning (EDPF) is presented as a construct and defined as a discrepancy between predicted premorbid ability and current test performance that is so atypical of individuals with true neurocognitive impairment that it is likely the product of performance invalidity. New embedded PVTs (EDPF-FSIQ, EDPF-VW, and EDPF-PP) were derived by comparing scores from the WAIS-IV to TOPF demographically predicted premorbid estimates and then examined for classification accuracy. PARTICIPANTS AND METHODS: After excluding for dementia, intellectual disability, and left-sided stroke, participants (n = 230) were grouped according to number of PVTs failed. ROC analyses were conducted to determine the accuracy of EDPF indices in classifying patients as failing 0 or ≥2 PVTs within both a mixed neuropsychological outpatient sample and according to specific diagnostic criterion groups. RESULTS: Significant group differences emerged for all EDPF indices (p < .001). EDPF-FSIQ resulted in an AUC of .837, classifying patients with 56% sensitivity at ≥90% specificity, and EDPF-VW resulted in an AUC of .850, classifying patients with 61% sensitivity at ≥90% specificity. Accuracy remained high across diagnostic groups (i.e. neurocognitive, moderate/severe TBI, and psychiatric) for EDPF-VW and EDPF-FSIQ, whereas specificity declined for EDPF-PP in patients with mixed neurocognitive disorders. Overall, classification accuracy rates exceeded those of Reliable Digit Span. CONCLUSIONS: Both EDPF-FSIQ and EDPF-VW demonstrated excellent discrimination between patients providing valid versus invalid test performance. Unique advantages of EDPF validity measures include incorporation of demographic estimates of premorbid ability and examination of performances on multiple tests spanning different cognitive domains.

Predictors of fatigue and poor sleep in adult survivors of childhood Hodgkin's lymphoma: a report from the Childhood Cancer Survivor Study.

PURPOSE: Survivors of pediatric Hodgkin's lymphoma (HL) are at risk for a number of debilitating late effects. Excessive fatigue and poor sleep quality are primary complaints of HL survivors. Understanding the emotional and physical factors that influence fatigue and sleep quality may provide opportunities for intervention to improve health-related quality of life for HL survivors. METHODS: Data from 751 adult survivors of childhood HL who participated in the Childhood Cancer Survivor Study (CCSS) from 2000-2002 were analyzed. Multivariable logistic regression analyses investigated the demographic, psychological, and physical variables that predicted clinically significant levels of poor sleep quality, fatigue, and excessive daytime sleepiness. RESULTS: Survivors' self-reported level of emotional distress, pain, and physical functioning limitations did not differ from population norms. Clinically elevated levels of emotional distress (OR 8.38, 95% CI 4.28-16.42) and pain (OR 3.73, 95% CI 2.09-6.67) increased the risk for endorsing elevated levels of fatigue. Survivors with elevated levels of emotional distress (OR 6.83, 95% CI 2.71-15.90) and pain (OR 5.27, 95% CI 1.78-15.61) were more likely to report poor sleep quality. Pain (OR 2.11, 95% CI 1.39-3.34) was related to excessive daytime sleepiness. CONCLUSIONS: Emotional and physical factors are associated with elevated levels of fatigue, excessive daytime sleepiness, and poor sleep quality in survivors of pediatric HL. This is consistent with findings from research conducted with non-cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS: These results suggest that interventions designed to target sleep and fatigue difficulties in the general population may be well suited for pediatric HL survivors as well.

Changes in sleep and fatigue in newly treated pediatric oncology patients.

BACKGROUND: Fatigue has been reported as one of the most distressing symptoms in oncology patients, yet few have investigated the longitudinal course of sleep and fatigue in newly diagnosed pediatric oncology patients. PROCEDURE: To longitudinally assess presence and changes of sleep complaints and fatigue, we administered questionnaires designed to measure sleep complaints, sleep habits, daytime sleepiness, and fatigue to parents of pediatric oncology patients ages 2-18 and to pediatric oncology patients, themselves, ages 8-18 within 30 days of diagnosis (n = 170) and again 8 weeks later (n = 153). RESULTS: Bedtimes, wake times, and sleep duration remained relatively stable across the first 8 weeks of treatment. Sleep duration and fatigue were not related for the entire sample, though children's self-reported sleep duration was positively correlated with fatigue only at the baseline time point. Parent reports of fatigue significantly decreased for leukemia patients but remained rather high for solid tumor and brain tumor patients. CONCLUSIONS: Because fatigue remained high for solid tumor and brain tumor patients across the initial 8 weeks of treatment, this may highlight the need for intervention in this patient population.

Health care provider communication: an empirical model of therapeutic effectiveness.

BACKGROUND: Patients who are facing life-threatening and life-limiting cancer almost invariably experience psychological distress. Responding effectively requires therapeutic sensitivity and skill. In this study, we examined therapeutic effectiveness within the setting of cancer-related distress with the objective of understanding its constituent parts. METHODS: Seventy-eight experienced psychosocial oncology clinicians from 24 health care centers across Canada were invited to participate in 3 focus groups each. In total, 29 focus groups were held over 2 years, during which clinicians articulated the therapeutic factors deemed most helpful in mitigating patient psychosocial distress. The content of each focus group was summarized into major themes and was reviewed with participants to confirm their accuracy. Upon completion of the focus groups, workshops were held in various centers, eliciting participant feedback on an empirical model of therapeutic effectiveness based on the qualitative analysis of focus group data. RESULTS: Three primary, interrelated therapeutic domains emerged from the data, forming a model of optimal therapeutic effectiveness: 1) personal growth and self-care (domain A), 2) therapeutic approaches (domain B), and 3) creation of a safe space (domain C). Areas of domain overlap were identified and labeled accordingly: domain AB, therapeutic humility; domain BC, therapeutic pacing; and domain AC, therapeutic presence. CONCLUSIONS: This empirical model provides detailed insights regarding the elements and pedagogy of effective communication and psychosocial care for patients who are experiencing cancer-related distress.

The Patient Dignity Inventory: applications in the oncology setting.

BACKGROUND: The Patient Dignity Inventory (PDI) is a novel 25-item psychometric instrument, designed to identify multiple sources of distress (physical, functional, psychosocial, existential, and spiritual) commonly seen in patients who are terminally ill. It was also designed to help guide psychosocial clinicians in their work with patients. While its validity and reliability have been studied within the context of palliative care, its utility in clinical settings has not as yet been examined. PURPOSE: The purpose of this study was to determine how psychosocial oncology professionals would use the PDI with within their practice and what utility it might have across the broad spectrum of cancer. METHODS: Between October 2008 and January 2009, psychosocial oncology clinicians from across Canada were invited to use the PDI to determine their impressions of this approach in identifying distress and informing their practice. RESULTS: Ninety participants used the PDI and submitted a total of 429 feedback questionnaires detailing their experience with individual patients. In 76% of instances, the PDI revealed one or more previously unreported concerns; in 81% of instances, clinicians reported that the PDI facilitated their work. While it was used in a wide range of circumstances, clinicians were more inclined to apply the PDI to patients engaged in active treatment or palliation, rather than those in remission, having recently relapsed, or newly diagnosed. Besides its utility in identifying distress, the PDI enabled clinicians to provide more targeted therapeutic responses to areas of patient concern. CONCLUSIONS: While this study suggests various clinical applications of the PDI, it also provides an ideal forerunner for research that will directly engage patients living with cancer.