Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial.

Background: Primary brain tumor (PBT) patients experience higher levels of distress and anxiety than other solid tumor patients, particularly at the time of clinical evaluation when uncertainty about disease status is high ("scanxiety"). There is promising evidence supporting use of virtual reality (VR) to target psychological symptoms in other solid tumor patients, though PBT patients have not been studied extensively in this context. The primary aim of this phase 2 clinical trial is to establish the feasibility of a remote VR-based relaxation intervention for a PBT population, with secondary aims designed to determine preliminary efficacy of improving distress and anxiety symptoms. Methods: PBT patients (N=120) with upcoming MRI scans and clinical appointments who meet eligibility will be recruited to participate in a single arm trial conducted remotely through the NIH. Following completion of baseline assessments, participants will complete a 5-minute VR intervention via telehealth using a head-mounted immersive device while under supervision of the research team. Following the intervention, over the course of 1 month patients can use VR at their discretion with follow-up assessments done immediately post-VR intervention, as well as 1 week and 4 weeks later. Additionally, a qualitative phone interview will be conducted to assess patient satisfaction with the intervention. Discussion: Use of immersive VR is an innovative interventional approach to target distress and scanxiety symptoms in PBT patients who are at high risk for experiencing these symptoms leading into their clinical appointments. Findings from this study may inform design of a future multicenter randomized VR trial for PBT patients and may aid in development of similar interventions for other oncology populations. Trial Registration: clinicaltrials.gov (NCT04301089), registered 9 March 2020.

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial.

Purpose: Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation. Methods: English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews. Results: 55 patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain). Conclusion: This interim analysis confirmed feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy. Trial Registration: NCT04301089 registered on 3/9/2020.

Relationship between RANO-PRO Working Group standardised priority constructs and disease progression among malignant glioma patients: A retrospective cohort study.

Background: Recognising the importance of clinical outcomes assessments (COAs), the Response Assessment in Neuro-Oncology-Patient Reported Outcome (RANO-PRO) Working Group recommended inclusion of core symptoms and functions in clinical care or research for malignant glioma patients. This study evaluated the association of the recommended symptoms (pain, perceived cognition, seizures, aphasia, symptomatic adverse events) and functions (weakness, walking, work, usual activities) with disease progression in these patients. Methods: In this retrospective cohort study, patients with malignant glioma were included from the US National Cancer Institute Neuro-Oncology Branch Natural History Study (NOB-NHS) which follows primary central nervous system tumour patients aged 18 years and older throughout their disease trajectory. The M.D. Anderson Symptom Inventory-Brain Tumor (MDASI-BT), EQ-5D-3L, Karnofsky Performance Status (KPS), and Neurologic Function scores (NFS) were evaluated in relation to disease progression by chi-square tests, independent- and paired-samples t-tests, adjusted for multiple comparisons at first assessment and over time to a second assessment. Radiographic disease progression was determined on the interpretation of the imaging study by a radiologist and neuro-oncologist using standard criteria as part of clinical trial participation or routine standard of care. The priority constructs were evaluated to provide initial evidence of their relevance, relationship to disease status over time, and sensitivity to change in a diverse group of patients with malignant glioma. Findings: Seven hundred and sixty-five patients had enrolled into the NOB-NHS between September 1, 2016 and January 31, 2020. Three hundred and thirty-six patients had a diagnosis of a malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, and gliosarcoma) and were included in the current study. The sample was 64% male (n = 215), 36% female (n = 121), median age of 52 years (IQR = 18.75), 82% White (n = 276), and 65% had tumour recurrence (n = 219). One hundred and fifty-four (46%) had radiographic disease progression. Difficulty remembering, fatigue, and weakness were worse in the group whose imaging was interpreted as radiographic disease progression versus stable disease, as well as the functions of walking, work, activity, and self-care (1.1 < difference < 1.8). Patients with disease progression were four times more likely to have a poor KPS (≤80) and worse NFS. Among patients with disease progression at a second assessment (n = 112), all symptoms, except seizures, worsened between first assessment and disease progression and up to 22% of patients (n = 25) reported worsening mobility, self-care, and usual activity; 46% (n = 51) and 35% (n = 30) had worsened KPS and NFS, respectively. On average, 4 symptoms or functions (SD = 3) were reported as moderate-to-severe and 30% (n = 33) and 23% (n = 26) had a change to moderate-to-severe fatigue and walking, respectively, at time of disease progression. Over 7% of patients with worsening (n = 7 of 100) reported every symptom and function as having changed the most severely including seizures with fatigue and activity reported as the top symptom and function, respectively. Interpretation: The identified core symptoms and functions worsened at the time of progression, supporting the relevance and sensitivity of the priority constructs identified by the RANO-PRO Working Group for clinical care and clinical trials for malignant glioma patients. Funding: The Natural History Study is supported by Intramural Project 1ZIABC011786-03.

Exploring the prevalence and burden of sleep disturbance in primary brain tumor patients.

Background: Sleep disturbance (SD) is common in patients with cancer and has been associated with worse clinical outcomes. This cross-sectional study explored the prevalence of SD in a primary brain tumor (PBT) population, identified associated demographic and clinical characteristics, and investigated co-occurrence of SD with other symptoms and mood disturbance. Methods: Demographic, clinical characteristics, MD Anderson Symptom Inventory-Brain Tumor, and Patient Reported Outcome Measurement Information System Depression and Anxiety Short-Forms were collected from PBT patients at study entry. Descriptive statistics, Chi-square tests, and independent t-tests were used to report results. Results: The sample included 424 patients (58% male, 81% Caucasian) with a mean age of 49 years (range 18-81) and 58% with high-grade gliomas. Moderate-severe SD was reported in 19% of patients and was associated with younger age, poor Karnofsky Performance Status, tumor progression on MRI, and active corticosteroid use. Those with moderate-severe SD had higher overall symptom burden and reported more moderate-severe symptoms. These individuals also reported higher severity in affective and mood disturbance domains, with 3 to 4 times higher prevalence of depressive and anxiety symptoms, respectively. The most frequently co-occurring symptoms with SD were, drowsiness, and distress, though other symptoms typically associated with tumor progression also frequently co-occurred. Conclusions: PBT patients with moderate-severe SD are more symptomatic, have worse mood disturbance, and have several co-occurring symptoms. Targeting interventions for sleep could potentially alleviate other co-occurring symptoms, which may improve life quality for PBT patients. Future longitudinal work examining objective and detailed subjective sleep reports, as well as underlying genetic risk factors, will be important.

Assessing mobility in primary brain tumor patients: A descriptive feasibility study using two established mobility tests.

Background: Patients with primary brain tumors (PBT) face significant mobility issues related to their disease and/or treatment. Here, the authors describe the preliminary utility and feasibility of two established mobility measures, the Timed-Up-and-Go (TUG) and Five-Times Sit-to-Stand (TSS) tests, in quickly and objectively assessing the mobility status of PBT patients at a single institution's neuro-oncology clinic. Methods: Adult patients undergoing routine PBT care completed the TUG/TSS tests and MD Anderson Symptom Inventory-Brain Tumor module (MDASI-BT), which assessed symptom burden and interference with daily life, during clinic visits over a 6-month period. Research staff assessed feasibility metrics, including test completion times/rates, and collected demographic, clinical, and treatment data. Mann-Whitney tests, Kruskal-Wallis tests, and Spearman's rho correlations were used to interrogate relationships between TUG/TSS test completion times and patient characteristics. Results: The study cohort included 66 PBT patients, 59% male, with a median age of 47 years (range: 20-77). TUG/TSS tests were completed by 62 (94%) patients. Older patients (P < .001) and those who were newly diagnosed (P = .024), on corticosteroids (P = .025), or had poor (≤80) KPS (P < .01) took longer to complete the TUG/TSS tests. Worse activity-related (work, activity, and walking) interference was associated with longer TUG/TSS test completion times (P < .001). Conclusions: The TUG/TSS tests are feasible for use among PBT patients and may aid in clinical care. Older age, being newly diagnosed, using corticosteroids, poor (≤80) KPS, and high activity-related interference were associated with significant mobility impairment, highlighting the tests' potential clinical utility. Future investigations are warranted to longitudinally explore feasibility and utility in other practice and disease settings.

The state of neuro-oncology during the COVID-19 pandemic: a worldwide assessment.

BACKGROUND: It remains unknown how the COVID-19 pandemic has changed neuro-oncology clinical practice, training, and research efforts. METHODS: We performed an international survey of practitioners, scientists, and trainees from 21 neuro-oncology organizations across 6 continents, April 24-May 17, 2020. We assessed clinical practice and research environments, institutional preparedness and support, and perceived impact on patients. RESULTS: Of 582 respondents, 258 (45%) were US-based and 314 (55%) international. Ninety-four percent of participants reported changes in their clinical practice. Ninety-five percent of respondents converted at least some practice to telemedicine. Ten percent of practitioners felt the need to see patients in person, specifically because of billing concerns and pressure from their institutions. Sixty-seven percent of practitioners suspended enrollment for at least one clinical trial, including 62% suspending phase III trial enrollments. More than 50% believed neuro-oncology patients were at increased risk for COVID-19. Seventy-one percent of clinicians feared for their own personal safety or that of their families, specifically because of their clinical duties; 20% had inadequate personal protective equipment. While 69% reported increased stress, 44% received no psychosocial support from their institutions. Thirty-seven percent had salary reductions and 63% of researchers temporarily closed their laboratories. However, the pandemic created positive changes in perceived patient satisfaction, communication quality, and technology use to deliver care and mediate interactions with other practitioners. CONCLUSIONS: The pandemic has changed treatment schedules and limited investigational treatment options. Institutional lack of support created clinician and researcher anxiety. Communication with patients was satisfactory. We make recommendations to guide clinical and scientific infrastructure moving forward and address the personal challenges of providers and researchers.

Variations in attitudes towards stereotactic biopsy of adult diffuse midline glioma patients: a survey of members of the AANS/CNS Tumor Section.

PURPOSE: Diffuse midline gliomas are rare midline CNS malignancies that primarily affect children but can also affect adults. While radiation is standard treatment, prognosis remains fatal. Furthermore, due to its sensitive anatomic location, many physicians have been reluctant to perform biopsies without potential for improved prognosis. However, recent advancements in molecular-targeted therapeutics have encouraged greater tissue sampling. While the literature reflects this progress, the landscape of how clinicians actually manage these patients remains unclear. Our goal was to assess the attitudes of current practicing neurosurgical oncologists towards management of adult diffuse midline gliomas, reasons behind their practices, and factors that might influence these practices. METHODS: We created and distributed a survey with 16 multiple choice and open-ended questions to members of the Tumor Section of the Congress of Neurological Surgeons. RESULTS: A total of 81 physicians responded to the survey. Although time since training and volume of glioma patients did not significantly affect the decision to consider clinical trials or to offer biopsy, those that operated on fewer gliomas (< 25/year) were more likely to cite surgical morbidity as the primary reason not to biopsy these midline locations. Further, surgeons with access to more advanced molecular testing were significantly more likely to consider clinical trial eligibility when offering biopsies. CONCLUSION: Factors that affect the management of diffuse midline gliomas and the role of biopsy are relatively uniform across the field, however, there were a few notable differences that reflect the changes within the neuro-oncology field in response to clinical trials.

Identifying symptom recurrences in primary brain tumor patients using the MDASI-BT and qualitative interviews.

BACKGROUND: Identifying symptoms experienced throughout the disease trajectory is pivotal to understanding management of patient symptoms. Patient interviews to solicit input from those who have experienced these symptoms is one method to capture this perspective to validate symptoms included in patient reported outcomes (PRO) measures. METHODS: A thematic approach was used to identify themes within qualitative interviews. The MD Anderson Symptom Inventory- Brain Tumor (MDASI-BT) was completed by glioma patients. Descriptive statistics was used for analysis of the MDASI-BT. RESULTS: Thematic saturation was reached with 23 participants, with a median age of 53 (23-62), on treatment (57%) and diagnosed with a glioblastoma (48%). Patients endorsed 20 out of the 22 MDASI-BT symptoms (symptoms not reported: dry mouth, shortness of breath) during the interviews and with completion of the instrument (seizures and vomiting were not endorsed). Fatigue (55%), seizures (50%), and pain (50%) were common symptoms described by the sample. During treatment, more symptoms were identified with fatigue, hair loss, and nausea more problematic. Aside from itching and swelling (endorsed by 2 patients each), all other symptoms not included in the MDASI-BT instrument were endorsed by only one patient. CONCLUSIONS: Completion of the MDASI-BT, found patients reported on average 6.8 symptoms with 14% of reported symptoms (mean = 3) rated as moderate to severe. The findings demonstrate how applicable the MDASI-BT is in capturing significant symptoms experienced and how important it is to utilize throughout ones' care to manage symptoms effectively.

Relationship between symptom burden and health status: analysis of the MDASI-BT and EQ-5D.

BACKGROUND: Patients with glioma are highly symptomatic and often have functional limitations from the time of diagnosis. Measuring health status may have value in determining impact of disease. This study provided a description of health status and utility scores in glioma patients throughout the illness trajectory using the EQ-5D (a functional measure of general health status). Furthermore, it evaluated the information provided by the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT; a measure of symptom burden and interference) in describing health-related quality of life as assessed by the EQ-5D. METHODS: Glioma patients completed the EQ-5D and MDASI-BT. Disease and clinical details were collected by medical record review. Linear regression evaluated whether MDASI-BT scores adequately predict patient health outcomes measured by the EQ-5D. RESULTS: The sample included 100 patients (65% male, 78% with a glioblastoma, median age 52 [range, 20-75], 56% in active treatment). Seventy-two percent of patients reported functional limitations in at least 1 area. Extreme cases reported inability to perform usual activities (8%) and significant anxiety/depression (5%). The MDASI-BT neurologic factor and activity-related interference (walking/activity/work) explained 52% of the variability in the EQ-5D in this patient population while adjusting for the effect of tumor grade, recurrence status, and performance status. CONCLUSIONS: The majority of glioma patients reported at least 1 functional limitation on the EQ-5D. Over half of the variance in the EQ-5D was explained by the MDASI-BT, performance status, tumor grade, and recurrence status. The resultant model demonstrates the significant contribution of symptom burden on health status in glioma patients.

Association of genetic variants with fatigue in patients with malignant glioma.

BACKGROUND: Fatigue is a consistently reported, severe symptom among patients with gliomas throughout the disease trajectory. Genomic pathways associated with fatigue in glioma patients have yet to be identified. METHODS: Clinical factors (performance status, tumor details, age, gender) were collected by chart review on glioma patients with fatigue ("I have lack of energy" on Functional Assessment of Cancer Therapy-Brain), as well as available genotyping data. Candidate genes in clock and inflammatory pathways were identified from a literature review, of which 50 single nucleotide polymorphisms (SNPs) in 7 genes were available. Clinical factors and SNPs identified by univariate analyses were included in a multivariate model for moderate-severe fatigue. RESULTS: The study included 176 patients (median age = 47 years, 67% males). Moderate-severe fatigue was reported by 43%. Results from multivariate analysis revealed poor performance status and 2 SNPs were associated with fatigue severity. Moderate-severe fatigue was more common in patients with poor performance status (OR = 3.52, P < .01). For each additional copy of the minor allele in rs934945 (PER2) the odds of fatigue decreased (OR = 0.51, P < .05). For each additional copy of the minor allele in rs922270 (ARTNL2) the odds of fatigue increased (OR = 2.38, P < .01). Both of these genes are important in the circadian clock pathway, which has been implicated in diurnal preference, and duration and quality of sleep. No genes in the inflammatory pathway were associated with fatigue in the current study. CONCLUSIONS: Identifying patients at highest risk for fatigue during treatment allows for improved clinical monitoring and enrichment of patient selection for clinical trials.

Survivorship care planning in neuro-oncology.

Cancer patient survivorship has become a significant topic within oncology care for both adult and pediatric patients. Starting in 2005, the Institute of Medicine recommended the use of survivorship care plans to assist patients transitioning from active treatment to the posttreatment phase of their cancer care, a critical time for many patients. Since 2014 there has been a mandate within the United States for adult cancer patients treated with curative intent to receive survivorship care plans comprised of a treatment summary and a follow-up plan to facilitate a better understanding among patients of what to expect after treatment. In addition to a general oncology survivorship care plan, specific care plans have been created for breast, lung, prostate, and colon cancers, as well as lymphoma. A survivorship care plan specific to adult neuro-oncology has been developed by a multidisciplinary and interprofessional committee, with approval from the Society for Neuro-Oncology Guidelines Committee. It has been published in compendium with this review of survivorship care planning and available as a fillable PDF on the Society of Neuro-Oncology Guidelines Endorsement web page (https://www.soc-neuro-onc.org/SNO/Resources/Survivorship_Care_Plan.aspx). Implementation of this survivorship care plan provides a unique opportunity to begin addressing the range of survivorship issues our neuro-oncology patients navigate from diagnosis to end of life.

Clinical presentation and outcomes for adult ependymoma patients.

BACKGROUND: Outcomes projects can be a catalyst for determining disease- and treatment-related consequences for patients with rare tumors. The Adult Ependymoma Outcomes (AEO) survey uses self-reported experience to evaluate how this tumor affects patient groups throughout the illness trajectory. METHODS: Patients completed the AEO survey via a Web-based portal. The survey included questions on treatment, tumor recurrence, and current health status; the MD Anderson Symptom Inventory Brain Tumor and Spine Tumor modules; and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). RESULTS: The sample included 264 participants (57% female) with a median age of 46 years (range, 18-77 years). Radiation treatment was commonly used for patients who had brain involvement (χ2 (1) = 20.7; P < .001), underwent a partial resection (43%; χ2 (3) = 15.4; P < .001), or had a grade 3 tumor (41%; χ2 (2) = 18.8; P < .001). Recurrence occurred in a small group (29%), with grade 1 tumor patients 2.6 times more likely and grade 3 tumor patients 2.5 times more likely to experience recurrence than those with grade 2 tumors. Spine tumor patients had a higher symptom burden (mean, 2.8; scale, 0-10) than brain tumor patients (t(247) = -4.0), and they reported more moderate to severe symptoms (rating ≥ 5; 29%) than their counterparts (18%). Within the physical health portion of the SF-36, spine tumor patients reported worse health with respect to bodily pain (t(249) = 6.8; P < .001), physical functioning (t(252) = 4.1; P < .001), and vitality (t(202.2) = 3.0; P < .003). CONCLUSIONS: These results demonstrate the feasibility of implementing outcomes projects that report on the clinical and demographic characteristics of a rare patient population, and they underscore the importance of outcomes data in understanding disease-related issues. Cancer 2017;123:494-501. © 2016 American Cancer Society.

The symptom burden of primary brain tumors: evidence for a core set of tumor- and treatment-related symptoms.

BACKGROUND: A set of symptoms common across cancers has been proposed to enhance quality of care and clinical research in solid tumor patients. Using data from several clinical studies, this study evaluated these symptoms in primary brain tumor patients. METHODS: Symptom report data using the MD Anderson Symptom Instrument -Brain Tumor (MDASI-BT) from 621 patients enrolled in 8 clinical studies was used. The prevalence and severity of symptoms were reported as they relate to tumor grade, treatment stage and KPS. RESULTS: The sample was primarily white (82.5%) males (59%) with high-grade gliomas (75%). More than 50% of patients reported at least 10 concurrent symptoms, and 40% of patients reporting having at least 3 moderate-to-severe symptoms. Fatigue, drowsiness, difficulty remembering, disturbed sleep, and distress were the most severe symptoms reported by all tumor grades. Functional interference of symptoms with ability to work, perform activities, walk, and enjoy life was reported by more than 25% of patients. CONCLUSIONS: These results support a core set of symptoms, common in other solid tumor patients, that may impact clinical care and assessment of treatment benefit. Although only 5 of the Center for Medical Technology Policy list of proposed core symptoms met criteria for inclusion in this sample, 5 of the other proposed core symptoms were also reported in similar frequency as reported in the other cancer populations. This primary brain tumor population differed from other solid tumor patients in that other symptoms, which could be disease related, were more prevalent and thus should also be collected for these patients.

Hope and mood changes throughout the primary brain tumor illness trajectory.

BACKGROUND: The ambiguity of defining hope impacts the level of readiness faced by health care professionals treating patients with glioma, a disease with unpredictable outcomes. This study describes the report of hope and the relationship between hope and mood in adult brain tumor patients at various points in the illness trajectory. METHODS: This was a cross-sectional study with data collection including use of the Herth Hope Index (HHI), the Profile of Mood States-Short Form (POMS-SF), and clinical information. Descriptive statistics were used to report sample characteristics. Spearman's rho and Mann-Whitney tests were used to compare and differentiate scores. RESULTS: Eighty-two patients ranging in age from 22 to 78 years (median, 44.5 y) participated in the study. Patients were primarily male (57.3%), married (76.8%), and had a high-grade glioma (35.4%). Nearly half had recurrence, and more than 20% were on active treatment. The overall HHI total score for the sample was 41.32 (range: 13-48). Patients with recurrence had a lower HHI interconnectedness (median = 14.00) score and higher total mood disturbance (median = 14.00) compared with patients without recurrence (median = 15.00 and median = 0.00, respectively; P < .05). All negative mood states on the POMS-SF were negatively correlated with HHI subscales. CONCLUSIONS: Overall, patients reporting more hope also reported less overall mood disturbance As expected, patients with tumor recurrence reported lower hope and higher mood disturbance than those who were newly diagnosed or without recurrence. Targeting interventions specifically tailored to an individual's needs for improvement in quality of life throughout the disease course may include measures to address hope in order to facilitate positive coping strategies.

The relationship between corticosteroids and symptoms in patients with primary brain tumors: utility of the Dexamethasone Symptom Questionnaire-Chronic.

BACKGROUND: Corticosteroids can have many side effects that impact the patient's quality of life and functional status. The Dexamethasone Symptom Questionnaire-Chronic (DSQ-C) was developed to report corticosteroid side effects. This study's objective was to evaluate the utility of the DSQ-C and report associated signs and symptoms in brain tumor patients. METHODS: Data collection included demographic and disease characteristics and the DSQ-C. Descriptive statistics were used to report associations among variables. Linear regression models were applied to assess the effects of the cumulative daily dose (mg/d × total d) on DSQ-C scores. Psychometrics included factor analysis to assess construct validity and Cronbach's alpha for internal consistency. RESULTS: Ninety-six adult patients with primary (77%) or metastatic (23%) brain tumors participated, with 74% on corticosteroids. Participants were primarily white (83%) males (65%) between 20 and 75 years of age (median, 53). Median corticosteroid dose duration was 4 mg/day for 1 month (range, 0-26 mo). The DSQ-C scores ranged from 17 to 54 (mean of 27), with 35% reporting increased appetite and trouble sleeping. Factor analysis indicated 6 underlying constructs explaining 53% of variance. DSQ-C internal consistency (reliability) was 0.77. The DSQ-C discriminated between patients who were on steroids and those who were not (P < .01), and cumulative dose predicted DSQ-C scores (P < .001). CONCLUSIONS: This study demonstrated the potential use of the DSQ-C as a screening tool for side effects associated with corticosteroid use in brain tumor patients. Future analyses should include longitudinal evaluation of severity and biologic underpinnings of variability of timing and severity of symptoms.

Significant predictors of patients' uncertainty in primary brain tumors.

Patients with primary brain tumors (PBT) face uncertainty related to prognosis, symptoms and treatment response and toxicity. Uncertainty is correlated to negative mood states and symptom severity and interference. This study identified predictors of uncertainty during different treatment stages (newly-diagnosed, on treatment, followed-up without active treatment). One hundred eighty six patients with PBT were accrued at various points in the illness trajectory. Data collection tools included: a clinical checklist/a demographic data sheet/the Mishel Uncertainty in Illness Scale-Brain Tumor Form. The structured additive regression model was used to identify significant demographic and clinical predictors of illness-related uncertainty. Participants were primarily white (80 %) males (53 %). They ranged in age from 19-80 (mean = 44.2 ± 12.6). Thirty-two of the 186 patients were newly-diagnosed, 64 were on treatment at the time of clinical visit with MRI evaluation, 21 were without MRI, and 69 were not on active treatment. Three subscales (ambiguity/inconsistency; unpredictability-disease prognoses; unpredictability-symptoms and other triggers) were different amongst the treatment groups (P < .01). However, patients' uncertainty during active treatment was as high as in newly-diagnosed period. Other than treatment stages, change of employment status due to the illness was the most significant predictor of illness-related uncertainty. The illness trajectory of PBT remains ambiguous, complex, and unpredictable, leading to a high incidence of uncertainty. There was variation in the subscales of uncertainty depending on treatment status. Although patients who are newly diagnosed reported the highest scores on most of the subscales, patients on treatment felt more uncertain about unpredictability of symptoms than other groups. Due to the complexity and impact of the disease, associated symptoms, and interference with functional status, comprehensive assessment of patients is necessary throughout the illness trajectory.

Personal health records, symptoms, uncertainty, and mood in brain tumor patients.

BACKGROUND: The advantages of patient access to the electronic medical record (EMR) through integrated personal health records (PHR) may be substantial, and foremost is the enhanced information flow between patient and practitioner. Because this is an emerging technology, the actualized benefits to complex patient groups remain largely unknown. MD Anderson Cancer Center provides web-based PHR portal access to the EMR including clinic notes, MRI results, and pathology reports. This study sought to evaluate PHR use by glioma patients. METHODS: Cross-sectional survey and PHR-derived user data from 186 patients were analyzed using descriptive and inferential statistics. Logistic regression assessed disparities between users and nonusers. Dependence of PHR access on treatment stage was tested through linear regression. Path analysis evaluated PHR access, disease-related uncertainty, symptom experience, and mood. RESULTS: Patients averaged 44.2 years (range 19y-80y), 77% had a high-grade tumor, and 60% had accessed PHR at least one time (range 0-126). Strongest predictors of access included education level (college level or higher), low performance status, middle income, and in-state residency. Patients undergoing treatment were more active users. PHR access was associated with lower disease-related uncertainty and lower symptom severity. Mood was not directly related to PHR use but mediated an association between symptom severity and uncertainty. CONCLUSIONS: While many reports presume better disease and symptom understanding for patients with EMR access, this study is the first to correlate PHR use to lower patient uncertainty levels. Early examination of PHR provides an important basis for critical evaluation and optimization to better structure this benefit for brain tumor patients.

Uncertainty, mood states, and symptom distress in patients with primary brain tumors: analysis of a conceptual model using structural equation modeling.

BACKGROUND: Patients with primary brain tumors (PBTs) face uncertainty related to prognosis, symptoms, treatment response, and toxicity. The authors of this report examined the direct/indirect relations among patients' uncertainty, mood states, and symptoms. METHODS: In total, 186 patients with PBTs were accrued at various points in the illness trajectory. Data-collection tools included an investigator-completed clinician checklist, a patient-completed demographic data sheet, the Mishel Uncertainty in Illness Scale-Brain Tumor Form (MUIS-BT), the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT), and the Profile of Mood States-Short Form (POMS-SF). Structural equation modeling was used to explore correlations among variables. RESULTS: Participants were primarily white (80%) men (53%) with a variety of brain tumors. They ranged in age from 19 to 80 years (mean ± standard deviation, 44.2 ± 12.6 years). Lower functional status and earlier point in the illness trajectory were associated with greater uncertainty (P < .01 for both). Uncertainty (P < .05), except in the model of "confusion," and the 5 negative mood states measured by the POMS-SF were directly associated with symptom severity perceived by patients (P < .01 for all). The impact of uncertainty on perceived symptom severity also was mediated significantly by mood states. CONCLUSIONS: The results from the study clearly demonstrated distinct pathways for the relations between uncertainty-mood states-symptom severity for patients with PBTs. Uncertainty in patients with PBTs is higher for those who have a poor performance status and directly impacts negative mood states, which mediate patient-perceived symptom severity. This conceptual model suggests that interventions designed to reduce uncertainty or that target mood states may help lessen patients' perception of symptom severity, which, in turn, may result in better treatment outcomes and quality of life.

Validation of the Mishel's uncertainty in illness scale-brain tumor form (MUIS-BT).

The Mishel uncertainty in illness scale (MUIS) has been used extensively with other solid tumors throughout the continuum of illness. Interventions to manage uncertainty have been shown to improve mood and symptoms. Patients with primary brain tumors (PBT) face uncertainty related to diagnosis, prognosis, symptoms and response. Modifying the MUIS to depict uncertainty in PBT patients will help define this issue and allow for interventions to improve quality of life. Initially, 15 experts reviewed the content validity of the MUIS-brain tumor form (MUIS-BT). Patients diagnosed with PBT then participated in the study to test validity and reliability. Data was collected at one point in time. Six out of 33 items in the original MUIS were modified to better describe PBT patients' uncertainty. 32 of the 186 patients in the second-stage of the study were newly diagnosed with PBT, 85 were on treatment, and 69 were followed-up without active treatment. The validity of the MUIS-BT was demonstrated by its correlations with mood states (P < 0.01) and symptom severity (P < 0.01) and interference (P < 0.01). The MUIS-BT measures four constructs: ambiguity/inconsistency, unpredictability of disease prognosis, unpredictability of symptoms and other triggers, and complexity. Cronbach's alphas of the four subscales were 0.90, 0.77, 0.75 and 0.65, respectively. The 33-item MUIS-BT demonstrated adequate select measures of validity and reliability in PBT patients. Based on this initial validation and significant correlations with symptom distress and mood states, further understanding of uncertainty and evaluation of measures to help manage patients' uncertainty can be evaluated which in turn may improve coping and quality of life.