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More than one-third of cancer survivors experience significant residual symptoms after treatment completion. Fatigue and sleep disruption often co-occur and exacerbate each other. The purpose of this preliminary analysis was to examine the effect of a chronotypically tailored light therapy on fatigue and sleep disruption in female survivors 1-3 years post-completion of chemotherapy and/or radiation for stage I to III breast cancer. The data for this analysis were collected as part of an ongoing two-group randomized controlled trial (NCT03304587). Participants were randomized to receive either bright blue-green light (experimental) or dim red light (control). Light therapy was self-administered using a light visor cap at home. Both groups received 30-min daily light therapy for 14 consecutive days either between 19:00 and 20:00 h (for morning chronotypes) or within 30 min of waking in the morning (for evening chronotypes). Fatigue and sleep quality were self-reported using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue, PROMIS-Sleep Disturbance, Pittsburgh Sleep Quality Index, and a daily log before (pre-test) and following the light intervention (post-test). Linear mixed model analysis or generalized estimating equations examined group difference overtime adjusting for pre-test scores. No between-group differences were found. However, after adjusting for the baseline fatigue, the experimental group reported significant decreases in fatigue (p < .001) and sleep disturbance (p = .024) overtime. The experimental group also reported significantly better subjective sleep quality after 14 d of light therapy (p = .017). Positive trends in sleep latency, sleep duration, night-time awakenings, and early morning awakenings were also observed. Unexpectedly, sleep disturbance significantly decreased in the control group (p = .030). Those who received dim light control reported significantly shorter sleep latency (p = .002), longer total sleep time (p = .042), and greater habitual sleep efficiency (p = .042). These findings suggest that bright light therapy significantly improved post-treatment fatigue and subjective sleep quality in breast cancer survivors. Although it remains to be confirmed, the findings additionally show unexpected benefits of dim light on sleep. Properly timed light exposure may optimize the therapeutic effect and can be the key for successful light therapy. How the administration timing coupled with wavelengths (short vs. long) and intensity of light affecting fatigue and disrupted sleep requires further investigation.

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FD-OCT is a new imaging technique that allows unprecedented in vivo microlevel assessment of human carotid plaque morphologic patterns and stent-vessel interactions. Prior reports describing the use of this technique have used balloon occlusion of the target vessel or iodinated contrast media to facilitate imaging. We report, for the first time, in vivo FD-OCT imaging of human carotid arteries without the use of iodinated contrast material or balloon occlusion techniques.

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BACKGROUND AND PURPOSE: Carotid artery-related stroke is largely an embolic disease that has been correlated with inflammation, plaque rupture, and thrombus formation in "vulnerable" atherosclerotic plaque. Nevertheless, current guidelines for carotid revascularization in asymptomatic patients rely on the calculation of stenosis for risk assessment, a parameter that has been viewed with increasing skepticism. Intravascular OCT is an imaging technique that offers high axial resolution (10 µm), allowing an unprecedented micron-level assessment of human carotid plaque morphology. This observational article reports the first successful use of the newest iteration of this technology, FDOCT without balloon occlusion to assess human carotid artery disease and carotid stent-vessel interaction in vivo. MATERIALS AND METHODS: Four patients with asymptomatic carotid artery disease and ambiguous noninvasive and/or angiographic data underwent carotid FDOCT to assess risk and to formulate a treatment strategy. RESULTS: Findings include the unexpected demonstration of TCFAs, plaque rupture, thrombus, inflammation, and marked tissue prolapse through stent struts in patients without high-risk factors by conventional criteria, as well as low-risk features in a patient with a high-risk noninvasive study. The procedures were performed without safety issues or special accommodations for vessel occlusion. CONCLUSIONS: The present study demonstrates the technical feasibility of FDOCT in cervical carotid arteries. As such, this technology holds the promise of not only clarifying ambiguous data in individual patients but of providing data that might call for a future paradigm shift in the assessment of asymptomatic carotid artery disease.

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OBJECTIVE: Although many cancer patients experience multiple concurrent symptoms, most studies have either focused on the analysis of single symptoms, or have used methods such as factor analysis that make a priori assumptions about how the data is structured. This article addresses both limitations by first visually exploring the data to identify patterns in the co-occurrence of multiple symptoms, and then using those insights to select and develop quantitative measures to analyze and validate the results. METHODS: We used networks to visualize how 665 cancer patients reported 18 symptoms, and then quantitatively analyzed the observed patterns using degree of symptom overlap between patients, degree of symptom clustering using network modularity, clustering of symptoms based on agglomerative hierarchical clustering, and degree of nestedness of the symptoms based on the most frequently co-occurring symptoms for different sizes of symptom sets. These results were validated by assessing the statistical significance of the quantitative measures through comparison with random networks of the same size and distribution. RESULTS: The cancer symptoms tended to co-occur in a nested structure, where there was a small set of symptoms that co-occurred in many patients, and progressively larger sets of symptoms that co-occurred among a few patients. CONCLUSIONS: These results suggest that cancer symptoms co-occur in a nested pattern as opposed to distinct clusters, thereby demonstrating the value of exploratory network analyses to reveal complex relationships between patients and symptoms. The research also extends methods for exploring symptom co-occurrence, including methods for quantifying the degree of symptom overlap and for examining nested co-occurrence in co-occurrence data. Finally, the analysis also suggested implications for the design of systems that assist in symptom assessment and management. The main limitation of the study was that only one dataset was considered, and future studies should attempt to replicate the results in new data.

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Diagnosis of cancer is an emotionally traumatic event that significantly impacts the quality of life (QoL) of the patients. Progression to metastasis or recurrence of cancer after first diagnosis poses a greater threat to life that further increases this emotional trauma and can worsen the QoL. In this research we sought to explore the differences in QoL (symptom severity and physical functioning) experienced by primary non-metastatic (PNM), primary metastatic (PM) and recurrent (RC) cancer patients. Cancer patients recruited in two cognitive intervention trials formed the sample for this analysis. Data were analysed using longitudinal mixed models, with two interaction terms. Least square means were calculated and compared. Over the period of study RC patients reported the worst symptom severity and physical function followed by PM and PNM patients. Primary non-metastatic patients showed a steady decline in severity whereas PM and RC showed slight gains after the first follow-up. Primary non-metastatic patients displayed best physical functioning followed by PM and RC patients, and remained stable over time. Breast cancer patients displayed most variation in symptom severity among the three progression groups, whereas significant variation in physical function among the three groups was observed within all cancer sites.

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OBJECTIVE: There is no proven primary care treatment for patients with medically unexplained symptoms (MUS). We hypothesized that a long-term, multidimensional intervention by primary care providers would improve MUS patients' mental health. DESIGN: Clinical trial. SETTING: HMO in Lansing, MI. PARTICIPANTS: Patients from 18 to 65 years old with 2 consecutive years of high utilization were identified as having MUS by a reliable chart rating procedure; 206 subjects were randomized and 200 completed the study. INTERVENTION: From May 2000 to January 2003, 4 primary care clinicians deployed a 12-month intervention consisting of cognitive-behavioral, pharmacological, and other treatment modalities. A behaviorally defined patient-centered method was used by clinicians to facilitate this treatment and the provider-patient relationship. MAIN OUTCOME MEASURE: The primary endpoint was an improvement from baseline to 12 months of 4 or more points on the Mental Component Summary of the SF-36. RESULTS: Two hundred patients averaged 13.6 visits for the year preceding study. The average age was 47.7 years and 79.1% were females. Using intent to treat, 48 treatment and 34 control patients improved (odds ratio [OR]=1.92, 95% confidence interval [CI]: 1.08 to 3.40; P=.02). The relative benefit (relative "risk" for improving) was 1.47 (CI: 1.05 to 2.07), and the number needed to treat was 6.4 (95% CI: 0.89 to 11.89). The following baseline measures predicted improvement: severe mental dysfunction (P<.001), severe body pain (P=.039), nonsevere physical dysfunction (P=.003), and at least 16 years of education (P=.022); c-statistic=0.75. CONCLUSION: The first multidimensional intervention by primary care clinicians led to clinically significant improvement in MUS patients.

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BACKGROUND: A recent human therapeutic trial using intraputaminal infusion of glial cell-derived neurotrophic factor (GDNF) in Parkinson's disease (PD) was abruptly terminated, partly due to safety concerns raised by the finding of cerebellar lesions in monkeys given high-dose GDNF. METHODS: Magnetic resonance images from nine PD patients participating in this trial were analyzed to determine whether subtle volumetric or intensity changes could be detected in the cerebellum or elsewhere following GDNF treatment for over 1 year. Subtraction images were compared to a reference standard deviation map constructed by using identically-processed paired scans from 25 normal adults. In a separate voxel-based group morphometric (VBM) analysis of the same patient images, grey matter intensity was compared between pre and post-GDNF infusion scans using a repeated measures ANOVA with family-wise error threshold of P = 0.10. Two expert readers independently reviewed serial FLAIR images from all patients. RESULTS: (1) There were no significant cerebellar differences in any of the nine individual PD patients (difference image analysis), (2) there were no significant morphometric differences between pre- and post-GDNF scans (VBM), and (3) there were no signal abnormalities in the cerebellum detected on the FLAIR images in PD patients (clinical scan review). CONCLUSIONS: In concert with lack of evidence of cerebellar dysfunction on clinical examination, we find no imaging evidence of cerebellar injury in human subjects undergoing chronic intracerebral GDNF infusion.

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In this study, we investigated predictors of utilization of physician, hospital, and emergency room services in a sample of 277 elderly patients during the first year following a diagnosis of lung cancer. Data were obtained by a combination of patient interview and patient self-administered questionnaire at four intervals: baseline (wave 1), 3 months (wave 2), 6 months (wave 3), and 12 months (wave 4). Of the 277 patients, 242 provided data at wave 1, 209 at wave 2, 157 at wave 3, and 115 at wave 4. Symptomatology was assessed with the Symptom Experience Scale (simple count of symptoms present, chosen from a list of 37 cancer-related symptoms), and physical functioning was assessed with the Medical Outcomes Study 36-Item Short Form Health Survey. Analysis of covariance models were implemented separately for the active treatment period (0-6 months) and the continuing care period (6-12 months) to determine how age, gender, comorbidity, length of survival, treatment status, stage of disease, cancer site, physical functioning, and symptom count were related to physician visits, nights in hospital, and emergency room visits. During the active treatment period, patients with worse physical functioning reported more hospital nights (p=0.002) and more emergency room visits (p=0.013), while men reported more frequent emergency room visits (p=0.032) and more nights in hospital (p=0.006) than women. Patients reporting more symptoms also reported more physician visits (p=0.020). During the continuing care period, physical functioning had a similar relation to hospital nights (p=0.005) and emergency room visits (p=0.003), and patients with late-stage disease reported more physician visits than patients with early-stage disease (p=0.003).

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OBJECTIVES: Investigators and clinicians almost always rely on Diagnostic and Statistical Manual of Mental Disorder, 4th edition's (DSM-IV) somatoform disorders (and its derivative diagnoses) to characterize and identify patients with medically unexplained symptoms (MUS). Our objective was to evaluate this use by determining the prevalence of DSM-IV somatoform and nonsomatoform disorders in patients with MUS proven by a gold standard chart review. METHODS: In a community-based staff model HMO, we identified subjects for a clinical trial using a systematic and reliable chart rating procedure among high-utilizing MUS patients. Only baseline data are reported here. The World Health Organization Composite International Diagnostic Interview provided full and abridged DSM-IV diagnoses. Patients with full or abridged DSM-IV somatoform diagnoses were labeled "DSM somatoform-positive," whereas those without them were labeled "DSM somatoform-negative." RESULTS: Two hundred six MUS patients averaged 13.6 visits in the year preceding study, 79.1% were females, and the average age was 47.7 years. We found that 124 patients (60.2%) had a nonsomatoform ("psychiatric") DSM-IV diagnosis of any type; 36 (17.5%) had 2 full nonsomatoform diagnoses, and 41 (19.9%) had >2; 92 (44.7%) had some full anxiety diagnosis and 94 (45.6%) had either full depression or minor depression diagnoses. However, only 9 of 206 (4.4%) had any full DSM-IV somatoform diagnosis, and only 39 (18.9%) had abridged somatization disorder. Thus, 48 (23.3%) were "DSM somatoform-positive" and 158 (76.7%) were "DSM somatoform-negative." The latter exhibited less anxiety, depression, mental dysfunction, and psychosomatic symptoms (all p <.001) and less physical dysfunction (p = .011). Correlates of this DSM somatoform-negative status were female gender (p = .007), less severe mental (p = .007), and physical dysfunction (p = .004), a decreased proportion of MUS (p <.10), and less psychiatric comorbidity (p <.10); c-statistic = 0.77. CONCLUSION: We concluded that depression and anxiety characterized MUS patients better than the somatoform disorders. Our data suggested radically revising the somatoform disorders for DSM-V by incorporating a new, very large group of now-overlooked DSM somatoform-negative patients who were typically women with less severe dysfunction.

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BACKGROUND: The relationship between socioeconomic status and health care disparities in the incidence of brain tumors is unclear. OBJECTIVE: To identify the associations between age, sex, and Medicaid enrollment and the incidence of primary malignant brain tumors in Michigan in 1996 and 1997. METHODS: Records were obtained from the Michigan Cancer Surveillance Program on the 1,006 incident cases during this period and cross-checked with Medicaid enrollment files. RESULTS: Persons enrolled in Medicaid were more likely than non-enrolled persons to develop a malignant brain tumor of any type, a glioblastoma multiforme, and an astrocytoma for certain subgroups. In addition, incidence rates for malignant brain tumors in persons enrolled in Medicaid peaked at a younger age. CONCLUSION: Sociodemographic status may be associated with cerebral malignancy and should be considered when targeting treatment and educational interventions at persons at risk.

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PURPOSE/OBJECTIVES: To identify the number, type, and combination (cluster) of symptoms experienced by patients with lung cancer. DESIGN: A secondary analysis of data collected as part of a larger study. SETTING: 24 sites that included community hospitals, medical clinics, oncology clinics, and radiation-oncology clinics. SAMPLE: 220 patients newly diagnosed with lung cancer, ranging in age from 65-89 years (mean = 72 years, SD = 5.02), 38% with early-stage and 62% with late-stage lung cancer. METHODS: Subject self-report. FINDINGS: Factor analysis found that the symptoms of fatigue, nausea, weakness, appetite loss, weight loss, altered taste, and vomiting form a cluster. Initial staging of cancer, the number of comorbid conditions, and being treated with chemotherapy emerged as significant predictors of the symptoms reported. Few differences were noted between men and women. Correlation was found among the numbers of symptoms reported, symptom severity, and limitations attributed to symptoms. CONCLUSIONS: Patients with lung cancer report multiple distressing symptoms related to symptom severity and limitations. IMPLICATIONS FOR NURSING: Assessment of multiple symptoms is recommended in patients with lung cancer.

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BACKGROUND: There are no proven, comprehensive treatments in primary care for patients with medically unexplained symptoms (MUS) even though these patients have high levels of psychosocial distress, medical disability, costs, and utilization. Despite extensive care, these common patients often become worse. OBJECTIVE: We sought to identify an effective, research-based treatment that can be conducted by primary care personnel. DESIGN: We used our own experiences and files, consulted with experts, and conducted an extensive review of the literature to identify two things: 1). effective treatments from randomized controlled trials for MUS patients in primary care and in specialty settings; and 2). any type of treatment study in a related area that might inform primary care treatment, for example, depression, provider-patient relationship. MAIN RESULTS: We developed a multidimensional treatment plan by integrating several areas of the literature: collaborative/stepped care, cognitive-behavioral treatment, and the provider-patient relationship. The treatment is designed for primary care personnel (physicians, physician assistants, nurse practitioners) and deployed intensively at the outset; visit intervals are progressively increased as stability and improvement occur. CONCLUSION: Providing a comprehensive treatment plan for chronic, high-utilizing MUS patients removes one barrier to treating this common problem effectively in primary care by primary care personnel.

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Patients with medically unexplained symptoms (MUS) often are a source of frustration for clinicians, and despite high quality biomedical attention and frequent diagnostic tests, they have poor health outcomes. Following upon progress in depression treatment approaches, we developed a multidimensional treatment protocol for deployment by primary care personnel. This multi-faceted intervention for MUS patients emphasized cognitive-behavioral principles, the provider-patient relationship, pharmacological management, and treating comorbid medical diseases. We deployed it in an HMO using nurse practitioners (NP) to deliver the intervention to 101 patients, while 102 controls continued to receive medical care from their usual primary care physician. Successful deployment of the intervention required training the NPs, continuing support for the NPs in their management of this difficult population, and establishing strong communication links with the HMO. This paper addresses the practical considerations of using primary care personnel to implement a complex intervention in primary care, and it includes a discussion of special challenges encountered as well as solutions developed to overcome them.

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We obtained medical claim files covering a period of 1 year prior to breast cancer diagnosis and the year following diagnosis for 204 women and estimated the cost of their treatment. We used log-linear regression controlling for age, comorbidity, physical functioning, and disease stage. To retransform the mean costs, we estimated separate smearing factors for surgical and adjuvant care types. The adjusted mean costs for breast cancer care ranged from $16,226 to $39,305 depending on the treatment provided with mastectomy being the least expensive option. Breast-conserving surgery (BCS) was more expensive because most women have multiple surgeries after the initial BCS and require adjuvant care. If the first surgery was a mastectomy, medical care use tends to return to precancer spending levels within a few months. Over one-half of the women in this study had multiple surgeries following diagnosis, leading to substantial costs and unknown morbidity.

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Colorectal cancer constitutes a major health problem for elderly patients. The disease and its stage, treatment, and attendant symptoms can have significant negative impact on the mental functioning of these patients. As part of a larger longitudinal study, 158 patients 65 years of age or older with an incident diagnosis of colorectal cancer were recruited from 23 sites within a Midwestern state. Random effects regression analysis techniques were used to analyze how age, gender, race, presence of a family caregiver, co-morbid conditions, stage of disease at diagnosis, and the time-dependent variables marital status, employment status, symptoms, physical functioning, social functioning, and treatment predict depressive symptomatology at four assessments over the 1st year following diagnosis. Gender, race, co-morbid conditions, physical functioning, social functioning, and symptoms were significant predictors of depressive symptomatology over the four waves of the study. Female patients, African Americans, and patients with two or more co-morbid conditions exhibited more depressive symptomatology. Both more symptoms and more restricted physical and social functioning corresponded to higher levels of depressive symptomatology. At a clinical level of patient care, these findings mandate early identification of psychosocial difficulties experienced, an individualized symptom management plan and the application of other interventions, such as information giving, reassurance and referral to other resources, with particular attention to African American and female patients.

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PURPOSE: The purpose of this study was to provide insight into the modest success of a physician and patient education and reminder program that improved screening rates from 37% to 49% among rural Medicaid-eligible patients in western Michigan. DESCRIPTION OF STUDY: The following four focus groups were conducted: African American men, African American women, White men, and White women, matched with moderators by gender and ethnicity. The sample was selected by contacting prior eligible screening refusers, completing groups with a convenience sample who had accepted screening. Twenty-one patients participated who were ages >50 years. The screening refusal rates were 19% for men and 9% for women. Open-ended questions guided the discussion of colorectal cancer (CRC) attitudes, beliefs, and practices. RESULTS: All participants believed in the efficacy of cancer screening. White women were better informed about screening purposes and procedures. The major barriers to screening were quality of care (ie, the perceived lack of offering screening and the follow-up of test results) and the potential for pain from screening or treatment of CRC, should it be discovered. CLINICAL IMPLICATIONS: Successful efforts to improve awareness of the importance and efficacy of screening must further address deeply held skepticism and fears about CRC screening in this population. A fruitful direction for this difficult problem appears to be improved communication (both negative and positive test results). Without feedback, patients with negative results may assume lack of provider follow-through.

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OBJECTIVES: Our objectives were to determine how patients who make frequent use of the medical system (high users) with medically unexplained symptoms met our chart-rating criteria for somatization and minor acute illness and what the stability of such diagnoses were over time. STUDY DESIGN: A chart review was performed at baseline and 1 and 2 years; we re-rated the charts of patients initially rated as having somatization, as well as a 15% sample of those with minor acute illness. POPULATION: We obtained a random sample of high-use patients (= 6 visits/year) aged 21 to 55 years who were identified from the management information system. OUTCOMES: We measured chart review designations as organic disease, somatization, or minor acute illness. RESULTS: Among 883 high users at baseline, 35% had organic diseases; 14% had somatization; and 51% had minor acute illness as their primary problems. No patients with initial minor acute diagnoses were reclassified as having somatization 1 or 2 years later, and all but 2 patients had minor acute illness in 1 or both follow-up years. CONCLUSIONS: Minor acute illness was more common among high users than somatization and organic diseases combined. It has not previously been studied but probably has been recognized by clinicians as the "worried well." Diagnoses of somatization were unstable over 2 years follow-up, while minor acute diagnoses were stable, supporting the latter as a valid entity.

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BACKGROUND: Lung cancer is a major health problem throughout the world. It is the leading cause of cancer-related death in men and women in the USA, with a 5-year survival rate of only 14%. It has been hypothesized that variables such as physical and social functioning, cancer-related symptomatology, comorbid conditions, cell type, and treatment are valid predictors of the psychological response to a diagnosis of lung cancer. METHODS: As part of a larger longitudinal study, 211 patients, 65 years of age or older, with an incident diagnosis of lung cancer, were recruited from 23 sites within a midwestern state. Repeated measures analysis of variance techniques were used to analyse how age, gender, comorbid conditions, stage of disease, cell type, as well as the time-dependent variables symptoms, physical functioning, social functioning, and treatment predict depressive symptomatology at four assessments over the first year following diagnosis. RESULTS: Social functioning (p<0.0001), symptoms severity (p<0.0001) and radiation treatment (p=0.017) were significant predictors of depressive symptomatology, with more symptoms and more restricted social functioning generally corresponding to higher levels of depressive symptomatology. Patients who had not received radiation treatment were more depressed than those who had received treatment at least 40 days prior to the interview. CONCLUSIONS: At a clinical level of patient care, these findings mandate early identification of psychosocial difficulties experienced, an individualized symptom management plan and the application of other interventions, such as information giving, reassurance and referral to other resources.

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Absence of the internal carotid artery (ICA) is a rare congenital anomaly. The embryology of the ICA and the common collateral pathways associated with its congenital absence are reviewed, with four new cases provided for illustration. While collateral blood flow may allow these patients to remain asymptomatic, two of our patients presented with transient ischemic attacks. Recognition of this anomaly has important implications during planned carotid or transsphenoidal surgery, in thromboembolic disease, and in the surveillance and detection of associated cerebral aneurysms.

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BACKGROUND: While recognized that loss of subjects over time may introduce bias and complicate statistical analysis in panel studies, it is seldom acknowledged that sampling bias starts with subjects who are eligible but do not participate. OBJECTIVES: Community-based recruiters identified 1,948 subjects as eligible to participate in a descriptive panel survey of older families with cancer. Focusing on the time between identification of eligible subjects until contact for the first interview for consenting subjects, the purpose of this study was to determine if subject or research design factors predicted who was more prone to nonparticipation. METHOD: A multivariate model explored the simultaneous effects of subject and research design characteristics on nonparticipation. Demographic and cancer characteristics, as well as features of the study protocol, were used as predictors in a multinomial logit regression model to enable a three-way comparison between nonconsenters (n = 748), consenters who dropped out prior to data collection (n = 208), and consenters who participated in the intake interview (n = 992). RESULTS: Age and cancer diagnosis played roles in whether consent was obtained, whereas race did not affect consent but raised odds of drop out after consent. Powerful evidence emerged that design features, such as if a caregiver participated, recruitment staff roles, and payment to recruiters, affected the probability of subjects not participating or dropping out before being interviewed. CONCLUSIONS: Findings suggest that both subject and research design characteristics affect the likelihood of nonparticipation in a panel study of older cancer patients and family caregivers. Future research involving testing of strategies addressing access and accrual issues, research staff roles, reimbursements, and responsiveness to the needs of research personnel, ill participants, and family members is warranted.

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