Perinatal HIV exposure and infection and caregiver depressive symptoms.

Survival is possible for children perinatally exposed to or infected by HIV in the post-combined antiretroviral therapy era and identifying factors affecting children's ability to thrive has public health significance. Caregiver mental health is one such factor to consider given its impact on child development, but previous work has not included a full complement of HIV exposure/infection groups within HIV-endemic settings. We compared depressive symptoms among caregivers of 3 groups of 6-10-year-olds in Uganda: children with perinatally acquired HIV infection (CPHIV, n = 102), children with perinatal HIV exposure, but no infection (CPHEU, n = 101), and children without perinatal HIV exposure or infection (CHUU, n = 103). The Hopkins Symptom Checklist was used to assess caregiver depressive symptoms. Generalized linear models were used to estimate group mean differences. Adjusted models included caregiver demographics, social support, and lifetime trauma. Depression symptoms were higher among CPHEU compared to CPHIV caregivers (model coefficient [B] = -3.5, 95%CI -5.3, -1.8). This finding was minimally attenuated following adjustment for covariates (B = -2.2, 95%CI -4.1, -0.4) and among biological mothers. At lower levels of social support and wealth, CPHEU caregivers reported higher levels of depression symptoms than CPHIV caregivers. Our findings point to unmet mental health needs among CPHEU caregivers.

Predictors of persistence of post-chemotherapy symptoms among survivors of solid tumor cancers.

CONTEXT: Late or residual symptoms diminish quality of life for many cancer survivors after completion of treatment. OBJECTIVES: Examine risk factors associated with persisting symptom burden after chemotherapy and the lack of symptom improvement over time. METHODS: Survivors who completed curative-intent chemotherapy within two years for solid tumors were enrolled into a symptom management trial. There were 375 survivors with two or more comorbid conditions or one comorbid condition and elevated depressive symptoms (pre-defined risk factors in the trial design) who received interventions and 71 survivors without these risk factors who did not receive interventions. For all survivors, symptoms were assessed at intake, 4, and 13 weeks and categorized as mild, moderate, or severe based on the interference with daily life. The probabilities of moderate or severe symptoms and symptom improvement were analyzed using generalized mixed-effects models in relation to comorbidity, depressive symptoms, age, sex, race/ethnicity, employment, time since chemotherapy completion, and physical function. Multiple symptoms were treated as nested within the survivor. RESULTS: Moderate or severe symptoms at baseline and the lack of improvement over time were associated with younger age and lower physical function over and above a greater number of comorbidities and elevated severity of depressive symptoms. CONCLUSION: Risk factors identified in this research (younger age, lower physical function, greater comorbidity, and higher depressive symptoms) can be used to allocate resources for post-treatment symptom management for cancer survivors in order to relieve symptoms that do not necessarily resolve with time.

Recruitment of older adults from long-term care settings for a longitudinal clinical trial.

Recruitment of residents for research from long-term care settings is known to be difficult. The purpose of this study was to summarize the effectiveness and cost in terms of time and dollars of recruitment methods for a cluster-randomized controlled clinical trial conducted in long-term care settings. This study was a retrospective, exploratory, descriptive analysis of recruitment data. After recruitment of 15 independent and assisted living communities, residents at each site were recruited to participate in the study using combinations of 12 different recruitment methods. Recruitment methods, time spent screening, and enrollment data were collected. Recruitment data were analyzed at the levels of site, research staff member, and participant. Over the study period, 279 older adults were screened and 172 enrolled from the 15 sites. Many participants were cognitively impaired. Research staff spent 39-89 h recruiting at each site and utilized an average of four different recruitment methods per site. Introductions of participants by site contacts yielded the most consented participants compared to other recruitment methods. Sites that had a dedicated recruiter utilized more recruiting methods and enrolled more participants than those without a dedicated recruiter. The cost of recruiting averaged $1490 per site and $93-$258 per enrollee (mean $144, standard deviation $58), but was more costly in larger facilities. Recruitment of older adults from long-term care communities requires multiple methods of recruitment, skilled recruitment staff, and trust with the staff and potential participants.

In utero/peripartum antiretroviral therapy exposure and mental health outcomes at 8-18 years old: A longitudinal comparative study of children with perinatally acquired HIV, children perinatally HIV exposed but uninfected, and children unexposed uninfected from Uganda.

In utero/peripartum antiretroviral therapy (IPA) exposure type was examined in relationship to mental health symptoms among 577 children with perinatally acquired HIV (CPHIV), children perinatally HIV exposed but uninfected (CHEU), and children HIV unexposed uninfected (CHUU). IPA exposure was categorized for CPHIV and CHEU as none, single-dose nevirapine with or without zidovudine (sdNVP±AZT), sdNVP+AZT+lamivudine (3TC), or combination antiretroviral therapy (cART). Anxiety and depressive symptoms were reported at baseline, 6-, and 12-month follow-up per behavioral assessment system for children. Multivariable linear mixed models were used to estimate differences (b) with 95% confidence intervals (95% CI) for IPA exposure types versus CHEU without IPA exposure. Depressive and anxiety symptoms were lower in CHUU relative to CHEU and CPHIV but did not differ between CPHIV and CHEU. CHEU with sdNVP±AZT exposure had greater anxiety (b = 0.51, 95% CI: [0.06, 0.96]) and depressive symptoms (b = 0.48, 95% CI: [0.07, 0.89]) than CHEU without IPA exposure. CHEU with sdNVP+AZT+3TC exposure had higher anxiety (b = 0.0.45, 95% CI: [0.03, 0.86]) and depressive symptoms (b = 0.72, 95% CI: [0.27, 1.17]) versus CHEU without IPA exposure. Depressive and anxiety symptoms were not different for CHEU and CPHIV exposed to cART (b = 0.12-0.60, 95% CI: [-0.41, 1.30]) and CHEU and CHUU (b = -0.04 to 0.08, 95% CI: [-0.24, 0.29]) without IPA exposure. Among CHEU, peripartum sdNVP±AZT and sdNVP+AZT+3TC but not cART compared to no IPA exposure was associated with clinically important elevations in anxiety and depressive symptoms. Monitoring of mental health trajectory of HIV-affected children considering IPA is needed to inform mental health interventions. Patient Contribution: Caregivers and their dependents provided consent for participation and collaborated with study team to identify mutually convenient times for protocol implementation.

Social Determinants of Health and Symptom Burden During Cancer Treatment.

BACKGROUND: Cancer survivors (defined as individuals from diagnosis to the end of life) in treatment experience multiple physical and psychological symptoms (e.g., fatigue, pain, depression, anxiety, disturbed sleep) that influence their well-being and treatment outcomes. Underrepresented cancer survivors may disproportionately experience greater symptom burden (number of symptoms, symptom severity, depression, anxiety). OBJECTIVES: The aim of this study was to examine the relationships of social determinants of health, including age, ethnicity, education, income and whether income meets the survivor's needs, neighborhood (rural vs. urban), access to healthcare (e.g., insurance), and social isolation, with symptom burden in cancer survivors. METHODS: This secondary analysis included baseline data from 400 cancer survivors of solid tumor cancers undergoing chemotherapy or targeted therapy who participated in a larger randomized trial of symptom management interventions. Symptom burden was measured by the Center for Epidemiological Studies-Depression scale for depression and Patient-Reported Outcomes Measurement Information System scores for anxiety and social isolation, summed severity index of 16 symptoms from the General Symptom Distress Scale, and the total number of symptoms. Self-reported comorbid conditions were measured using the Bayliss tool. General linear models were used to relate symptom measures (one at a time) to age, number of comorbid conditions, level of education, marital status, income meeting needs, and size of metropolitan neighborhood. Additional covariates included site of cancer, its treatment, and whether the cancer was metastatic. RESULTS: Non-Hispanic White survivors ( n = 191) were older and had more comorbid conditions, a higher proportion of metastatic cancers, and higher levels of education and income compared with Hispanic survivors ( n = 168) and non-Hispanic survivors of other races ( n = 41). Compared with the other two groups, Hispanic survivors had the lowest rate of health insurance availability, and non-Hispanic survivors of other races had the lowest social isolation. Age, number of comorbid conditions, and social isolation were significantly associated with number of symptoms, symptom severity, and depression. Age and social isolation were associated with anxiety. In addition, the symptom severity of non-Hispanic White survivors was lower than that of Hispanic survivors and non-Hispanic survivors of other races. DISCUSSION: These findings highlight the health disparities in symptom burden experienced among cancer survivors when considering their social determinants of health. Assessing these may help clinicians address health disparities in cancer care.

Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment.

OBJECTIVE: This study compared three ethnic/racial groups of informal cancer caregivers on social determinants of health and tested social determinants of health as predictors of psychological distress and caregiver burden. METHODS: This study was a secondary analysis of baseline data of a sequential multiple assignment randomized trial (SMART) testing symptom management interventions with caregiver-survivor dyads. Caregivers completed baseline measures of social determinants of health (SDoH), functional limitations, psychological distress, and caregiver burden. Hispanic, non-Hispanic White, and non-Hispanic other races caregivers were compared on these variables. Multivariate tests of associations between SDoH and caregiver burden and psychological distress were conducted in structural equation modeling with caregiver burden and psychological distress as latent variables. RESULTS: Hispanic caregivers reported significantly higher caregiver burden, specifically for finances, family, and schedules. Caregiver burden was significantly predicted by having income barely or not meeting needs, being female, socially isolated, married, Hispanic, and having poor physical functioning. Significant predictors of caregivers' psychological distress: being female, being socially isolated, and having poor physical functioning. CONCLUSION: Hispanic caregivers experience significant challenges associated with caregiver burden, especially if they are female, socially isolated, and have poor physical functioning. Assessment of these SDoH is important in caregiver health to provide supportive care during caregiving. CLINICAL TRIAL REGISTRATION NUMBER: NCT03743415 www.clinicaltrials.gov.

Depression among Underserved Rural and Urban Caregivers of Latinas with Breast Cancer.

Among Latino/as, informal caregiving duties are often deemed a family responsibility. Understanding psychological outcomes tied to caregivers of Latina breast cancer survivors is important to identify the impacts of cancer. Secondary analysis of baseline data collected in a randomized clinical trial (RCT) from 230 Latina breast cancer survivor-caregiver dyads. Characteristics of caregivers residing in rural/underserved and urban areas were compared using t- or chi-square tests. General linear models were used to analyze depressive symptoms in relation to residence, survivor-caregiver relationship, acculturation, obligation, reciprocity, and comorbidities. Urban residence was significantly associated with higher levels of depression controlling for survivor-caregiver relationship acculturation, obligation, reciprocity, and comorbidities. Mother caregivers had significantly higher levels of depression than other caregivers. Depression among Latino/a caregiver's providing care to an adult child is an important consideration as Latino/as are less likely to seek out/have access to mental health services than other groups.

Use of scheduled and unscheduled health services by cancer survivors and their caregivers.

PURPOSE: The purpose was to determine predictors of scheduled and unscheduled health services use by cancer survivors undergoing treatment and their informal caregivers. METHODS: English- or Spanish-speaking adult cancer survivors undergoing chemotherapy or targeted therapy for a solid tumor cancer identified a caregiver (N = 380 dyads). Health services use over 2 months was self-reported by survivors and caregivers. Logistic regression models were used to relate the likelihood of service use (hospitalizations, emergency department [ED] or urgent care visits, primary care, specialty care) to social determinants of health (age, sex, ethnicity, level of education, availability of health insurance), and number of comorbid conditions. Co-habitation with the other member of the dyad and other member's health services use were considered as additional explanatory variables. RESULTS: Number of comorbid conditions was predictive of the likelihood of scheduled health services use, both primary care and specialty care among caregivers, and primary care among survivors. Greater probability of specialty care use was associated with a higher level of education among survivors. Younger age and availability of health insurance were associated with greater unscheduled health services use (hospitalizations among survivors and urgent care or ED visits among caregivers). Unscheduled health services use of one member of the dyad was predictive of use by the other. CONCLUSIONS: These findings inform efforts to optimize health care use by encouraging greater use of scheduled and less use of unscheduled health services. These educational efforts need to be directed especially at younger survivors and caregivers.

Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial.

PURPOSE: To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients' symptoms. METHODS: In this SMART, patient-caregiver dyads were initially randomized to 4 weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4 weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4 weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models. RESULTS: In the comparison of 4 adaptive intervention sequences: reflexology for 8 weeks, reflexology for 4 weeks followed by MP for 4 weeks if no response to reflexology, MP for 8 weeks, and MP for 4 weeks followed by reflexology for 4 weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4 weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one. CONCLUSIONS: Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02759146.

Association of serum PUFA and linear growth over 12 months among 6-10 years old Ugandan children with or without HIV.

OBJECTIVE: To quantify PUFA-associated improvement in linear growth among children aged 6-10 years. DESIGN: Serum fatty acids (FA), including essential FA (EFA) (linoleic acid (LA) and α-linolenic acid (ALA)) were quantified at baseline using GC-MS technology. FA totals by class (n-3, n-6, n-9, PUFA and SFA) and FA ratios were calculated. Height-for-age Z-score (HAZ) relative to WHO population reference values were calculated longitudinally at baseline, 6 and 12 months. Linear regression models estimated PUFA, HIV status and their interaction-associated standardised mean difference (SMD) and 95 % CI in HAZ over 12 months. SETTING: Community controls and children connected to community health centre in Kampala, Uganda, were enrolled. PARTICIPANTS: Children perinatally HIV-infected (CPHIV, n 82), or HIV-exposed but uninfected (CHEU, n 76) and community controls (n 78). RESULTS: Relative to highest FA levels, low SFA (SMD = 0·31, 95 % CI: 0·03, 0·60), low Mead acid (SMD = 0·38, 95 % CI: 0·02, 0·74), low total n-9 (SMD = 0·44, 95 % CI: 0·08, 0·80) and low triene-to-tetraene ratio (SMD = 0·42, 95 % CI: 0·07, 0·77) predicted superior growth over 12 months. Conversely, low LA (SMD = -0·47, 95 % CI: -0·82, -0·12) and low total PUFA (sum of total n-3, total n-6 and Mead acid) (SMD = -0·33 to -0·39, 95 % CI: -0·71, -0·01) predicted growth deficit over 12 months follow-up, regardless of HIV status. CONCLUSION: Low n-3 FA (ALA, EPA and n-3 index) predicted growth deficits among community controls. EFA sufficiency may improve stature in school-aged children regardless of HIV status. Evaluating efficacy of diets low in total SFA, sufficient in EFA and enriched in n-3 FA for improving child growth is warranted.

Measuring Organizational Readiness for Change in Michigan's Home and Community-based Services Program: Instrument Adaptation and Psychometric Testing.

Short, valid, and reliable tools that measure organizational readiness are needed in practice. This study adapted and tested a previously developed instrument for measuring organizational readiness in a Medicaid Home and Community-Based Services (HCBS) program. The Texas Christian University Organizational Readiness for Change (TCU-ORC) scale was adapted and tested for validity and reliability in a sample of 522 registered nurses and social workers employed at 18 program sites. Structural validity was established using the exploratory factor analysis. Convergent validity was evaluated via correlations with the Implementation Leadership Scale (ILS) score. The adapted ORC scale consisted of 23 items. Cronbach's alphas for 5 subscales, Climate, Culture, Training, Motivation, and Pressure to Change exceeded .70. Convergent validity was supported by significant moderate correlations with the ILS. The adapted 23-item TCU-ORC scale is a valid and reliable instrument for measuring the organizational readiness for change in the Medicaid Home and Community-Based Services programs.

Factors affecting medication beliefs among patients newly prescribed oral oncolytic agents.

BACKGROUND: Prescribing oral oncolytic agents (OAs) for advanced cancers is increasing. AIMS: To explore changes in medication beliefs and the effects of symptom severity, cognitive effectiveness and depressive symptoms on medication beliefs over 12 weeks. METHODS: Secondary analysis of a randomized controlled trial, testing an intervention to promote symptom management and adherence [N = 230]. Questionnaires evaluated medication beliefs, symptom severity, depressive symptoms, and cognitive effectiveness. Linear mixed effects models were used for analyses. RESULTS: OA Necessity beliefs increased over time (mean difference 0.0112, SE = 0.055, p 0.04). Concern beliefs did not change and were lower for advanced cancers (-0.193, SE = 0.067, p < 0.01).Depressive symptoms were related to decreased Necessity beliefs (-0.012, SE = 0.005, p = 0.02), but not Concern beliefs. Medication beliefs were not associated with symptom severity or cognitive effectiveness. CONCLUSION: Patients with advanced cancer hold different medication beliefs compared to earlier staged cancers, lending insight into potential outcomes beyond adherence.

Attention Test Improvements from a Cluster Randomized Controlled Trial of Caregiver Training for HIV-Exposed/Uninfected Ugandan Preschool Children.

OBJECTIVE: To report vigilance attention outcomes from a cluster randomized controlled trial of early childhood development caregiver training for perinatally HIV-exposed/uninfected preschool-age children in rural Uganda. The Early Childhood Vigilance Test (ECVT) provides a webcam recording of proportion of time a child views an animation periodically moving across a computer screen. STUDY DESIGN: Sixty mothers/caregivers received biweekly year-long training sessions of the Mediational Intervention for Sensitizing Caregivers (MISC), and 59 mothers received biweekly training about nutrition, hygiene, and health care. Children were tested for attention at baseline, 6 months, and 12 months with the ECVT, in terms of proportion of time spent viewing a 6-minute animation of animals greeting the child and moving across the computer monitor screen. Time viewing the animation were scored by trained observers using ProCoder program for webcam scoring of proportion of time the child faced the animation. Mixed-effects modeling was used to compare ECVT outcomes for the 2 intervention groups. RESULTS: Unadjusted and adjusted (for age, sex, height, and ECVT at baseline) group differences on ECVT significantly favored the MISC arm at 6 months (P = .03; 95% CI (0.01, 0.11), effect size = 0.46) but not at 12 months. Both groups made significant gains in sustained attention across the year-long intervention (P = .021) with no significant interaction effects between time and treatment arms or sex. CONCLUSIONS: Caregiver early childhood development training enhanced attention in at-risk Ugandan children, which can be foundational to improved working memory and learning, and perhaps related to previous language benefits reported for this cohort. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00889395.

Longitudinal Dyadic Interdependence in Depression Symptoms of Caregivers Living with HIV in Uganda and Their Dependent Children's Neurodevelopment and Executive Behavior Outcomes.

We tested a model of dyadic interdependence in depression symptoms experienced by female caregivers living with HIV in Uganda (n = 288) and behavioral problems of their HIV-infected (n = 92) and perinatally HIV-exposed uninfected (HEU) children (n = 196). Three repeated measures of caregiver depression symptoms and child neurodevelopment and behavioral outcomes were related to their own outcomes at a previous time point (actor effects), and the outcomes of the other member of the dyad (partner effects). Caregiver depression and child behavioral problem were interdependent over the 24 months of observation. Caregiver depression at Tn predicted child's behavioral problems at Tn+1 (coefficient = 0.1220, SE = 0.0313, p < 0.01); child behavioral problems at Tn predicted maternal depression at Tn+1 (coefficient = 0.0984, SE = 0.0253, p < 0.01). Results suggest the importance of services addressing behavioral needs of affected children and mental health of their mothers.

RESUMEN: Evaluamos la interdependencia en relaciones diádicas entre síntomas de depresión en mujeres viviendo con VIH en Uganda (n = 288) y medidas de neurodesarollo y comportamiento en sus hijos no infectados pero expuestos a VIH (HEU) (n = 196). Tres mediciones repetidas de síntomas de depresión en mujeres y de neurodesarollo y comportamiento en niños estuvieron relacionadas con sus propios resultados en mediciones anteriores (efecto de actor), y con los resultados del otro miembro de la pareja (efecto de pareja). Síntomas depresivos y problemas conductuales fueron interdependientes durante los 24 meses de observación. Síntomas depresivos en mujeres en Tn predijeron problemas conductuales en el niño en Tn+1 (coeficiente = 0.1220, SE = 0.0313, p < 0.01); problemas conductuales en el niño en Tn predijeron depresión en mujeres en Tn+1 (coeficiente = 0.0984 , SE = 0.0253, p < 0.01). Los resultados sugieren la importancia de servicios que se enfoquen en atender problemas conductuales y de salud mental materna.

Supportive health education reduces health care utilization and costs in Latinas with breast cancer and their caregivers.

PURPOSE: To compare costs and relative cost savings from reductions in unscheduled health services use for two 8-week psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE]) delivered by telephone to Latinas with breast cancer and their informal caregivers. Cost information is required before adopting supportive care interventions as part of routine care. There is limited information on costs of producing supportive care interventions or their impact on service use. METHODS: Latinas and their caregivers were randomized to either TIPC or SHE. At baseline and month 4, hospitalizations and urgent care and emergency department (ED) visits in the previous month were recorded. These were compared by trial arm for 181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline. RESULTS: Total cost per 100 survivors was $28,695 for SHE and $27,399 for TIPC. Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [0.12, 0.88], p = .03). For hospitalizations, OR for SHE versus TIPC was 0.59, 95% CI [0.26, 1.37], p = .07. There were no differences between trial arms for caregiver health services use. Cost savings for SHE versus TIPC from reductions in health services use per 100 survivors ranged from $800 for urgent care to $17,000 for ED visits and $13,000 for hospitalizations. CONCLUSIONS: Based on this evidence, SHE can be a cost-saving supportive care solution that benefits not only survivors and caregivers, but also oncology practices reimbursed through episodes of care.

Economic evaluation of a farm-to-Special Supplemental Nutrition Programme for Women, Infants and Children intervention promoting vegetable consumption.

OBJECTIVE: To evaluate the cost and cost-effectiveness of a farm-to-Special Supplemental Nutrition Programme for Women, Infants and Children (WIC) intervention to promote vegetable intake and the redemption of WIC vouchers for produce purchases at farmers' markets. DESIGN: An economic analysis was undertaken using data from a pilot of the intervention. Vegetable intake was assessed with a reflection spectroscopy device (the Veggie Meter® [VM]) and via self-report. Voucher redemption was reported by WIC. Total and per participant intervention costs and cost-effectiveness ratios (expressed as cost per intervention effect) were estimated in 2019 US dollars over a 6-month period from the perspective of the agency implementing the intervention. SETTING: A large, urban WIC agency. PARTICIPANTS: Participants were 297 WIC-enrolled adults. RESULTS: Post-intervention, VM scores, self-reported vegetable intake and voucher redemption were higher in the intervention as compared with the control study group. Over the 6-month period, intervention costs were $31 092 ($194 unit cost per participant). Relative to the control group, the intervention cost $8·10 per increased VM score per participant, $3·85 per increased cup/d of vegetables consumed per participant and $3·29 per increased percentage point in voucher redemption per participant. CONCLUSIONS: Intervention costs and cost-effectiveness ratios compared favourably with those reported for other interventions targeting vegetable intake in low-income groups, suggesting that the programme may be cost effective in promoting vegetable purchases and consumption. As there is no benchmark against which to compare cost-effectiveness ratios expressed as cost per unit of effectiveness, conclusions regarding whether this is the case must await further research.

Reflexology and meditative practices for symptom management among people with cancer: Results from a sequential multiple assignment randomized trial.

Optimal sequencing of complementary therapies can help improve symptom management through nonpharmacological approaches. A 12-week sequential multiple assignment randomized trial comparing home-based reflexology and meditative practices on severity of fatigue and other symptoms was conducted among patients with cancer and their informal caregivers. Dyads were initially randomized to reflexology (N = 150), meditative practices (N = 150), or control (N = 47). If patient's fatigue did not improve (nonresponse) after 4 weeks of reflexology or meditative practices, the dyad was rerandomized to either add the other therapy or continue with the original therapy for weeks 5-8. Four decision rules (DRs) were compared: (1) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, continue with reflexology for another 4 weeks, thus providing a higher dose; (2) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, add meditative practices for the next 4 weeks; (3) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, continue meditative practices for another 4 weeks, thus providing a higher dose; and (4) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, add reflexology for the next 4 weeks. Symptoms were evaluated weekly using the M.D. Anderson Symptom Inventory (MDASI). Clinically, nurses can recommend either therapy since no differences were found among the 4 DRs, with the exception of lower severity for summed MDASI symptoms at week 8 for the use of reflexology only (DR-1) versus DR-2 (sequencing reflexology to meditative practices). Adding the other therapy for nonresponders after 4 weeks may not be warranted.

Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes.

BACKGROUND: Self-management of symptoms related to cancer and its treatment is important for maintaining treatment regimens and improving outcomes. PURPOSE: To determine factors associated with engagement in a symptom self-management intervention among patients initiating oral anticancer treatment. METHODS: This secondary analysis included 127 patients randomized to the medication adherence reminder and symptom management intervention in a recently completed trial. Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms. During eight automated telephone weekly calls, patients were asked to use the Toolkit to manage elevated symptoms. Toolkit use and symptoms were tracked weekly, and generalized linear mixed-effects models were used to determine factors predictive of Toolkit use. General linear modeling was used to relate the Toolkit use during intervention to postintervention symptom severity. RESULTS: Better cognitive function at intake into the trial and higher symptom burden were predictive of the patients' initial decision to try the Toolkit during Week 1. In subsequent weeks, Toolkit use in the previous week and worsening of symptoms were associated with greater odds of Toolkit use. The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks. CONCLUSIONS: Patients make realistic decisions regarding when to use a self-directed approach to self-management and are likely to use strategies when their symptoms are higher and to forego use once symptoms subside. CLINICAL TRIAL REGISTRATION: NCT02043184.

Eye Tracking Analysis of Visual Cues during Wayfinding in Early Stage Alzheimer's Disease.

INTRODUCTION: Persons with Alzheimer's disease (AD) have profound impairment in wayfinding, potentially related to a deficit in visual attention and selection of relevant environmental information. This study sought to determine differences in visual attention to salient visual cues and nonsalient cues (building features) in older adults with and without AD during active wayfinding in a large-scale, virtual reality spatial task. METHODS: Fifteen subjects (7 with AD and 8 controls without AD) were asked to find their way repeatedly during 10 trials in a virtual simulation of a senior retirement community. Subjects wore eye tracking glasses to capture visual fixations while wayfinding. The least square means (LSMs) and their standard errors (SEs) for percentage of fixations and duration of fixations on salient and nonsalient cues were estimated from the linear mixed effects models and compared by group (AD or control) and cue type. RESULTS: The group by cue type interaction was significant for both percentage of fixations (F(1, 13) = 6.79, p = 0.02) and duration of fixations (F(1, 13) = 4.87, p = 0.04). The AD group had significantly lower percentages of fixations on salient cues, LSM = 57.91 (SE = 2.44), compared to controls, LSM = 66.40 (SE = 2.19); p = 0.03. Persons with AD had a higher percentage of fixations on building features, LSM = 31.65 (SE = 2.18), than controls, LSM = 24.54 (SE = 1.95); p = 0.02. Shorter durations of fixations on salient cues were experienced by the AD group, LSM = 38.89 (SE = 1.69), than the control group, LSM = 44.69 (SE = 1.55); p = 0.02. DISCUSSION/CONCLUSION: Individuals with AD may have difficulty selecting relevant information for wayfinding as compared to normally aging individuals and attend more frequently than controls to irrelevant information. This may help explain the wayfinding difficulties seen in AD.

Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer.

PURPOSE: To examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregivers to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy. METHODS: Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analyzed using generalized estimating equations technique. RESULTS: Reflexology was more successful than attention control in producing responses for pain (OR = 1.84, 95% CI (1.05, 3.23), p = 0.03), with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants. CONCLUSIONS: Home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01582971.