Participants' perceptions support the coexistence of benefits and burdens of cancer clinical trial participation.

BACKGROUND: To advance oncology treatment for adults, comprehensive understanding of how and why people decide to enroll in, remain in, and withdraw from cancer clinical trials is needed. While quantitative findings provide insights into these benefits and burdens, they provide limited understanding of how adults with cancer appraise their situation and approach decisions to undertake a clinical trial. The goal of this mixed methods analysis was to conceptualize participants' assessment of benefits and burdens related to cancer clinical trial participation. MATERIALS AND METHODS: This sub-group analysis of 21 participants was part of a larger sequential, explanatory mixed methods study. We used Creamer's integrated approach to linking quantitative and qualitative data to assess convergence, with qualitative data explaining quantitative results. Participants were grouped into four categories based on quantitative benefit/burden scores and thematic analysis of their qualitative data was used to describe these categories. RESULTS: Across groups participants varied in descriptions of benefits and burdens of cancer clinical trial participation and reasons for participating. Those reporting high benefit/low burden described "seizing the opportunity to participate;" those reporting low benefit/low burden described "taking responsibility" through trial participation; those reporting low benefit/high burden described how they were "willing to endure," and those with high benefit/high burden emphasized "deciding to act." CONCLUSIONS: Participants' qualitative descriptions of benefits and burdens were more nuanced and dynamic than reflected in their quantitative ratings. Thus, current measures may be missing important concepts, such as logistic challenges of trial participation. Our results have implications for consenting procedures and decisional support guidance offered to patients and their caregivers.

Comparing symptom clusters in cancer survivors by cancer diagnosis: A latent class profile analysis.

PURPOSE: Research on symptom clusters in oncology is progressing, but knowledge gaps remain. One question is whether the number and types of symptom subgroups (i.e., latent classes) differ based on cancer diagnosis. The purpose of this study was to: (1) identify and compare latent class subgroups based on four highly prevalent symptoms (pain, fatigue, sleep disturbance, and depression), and (2) examine the differences in sociodemographic and clinical factors in the identified latent classes across the seven cancer types (i.e., prostate, non-small cell lung, non-Hodgkin's lymphoma, breast, uterine, cervical, and colorectal cancer). METHODS: This study is a cross-sectional secondary analysis of data obtained from the My-Health study in partnership with four Surveillance, Epidemiology, and End Results (SEER) cancer registries located in California (two), Louisiana, and New Jersey. The sample included 4,762 cancer survivors 6-13 months following diagnosis of one of the seven cancer types mentioned. Latent class profile analysis was used. RESULTS: Subjects were primarily young (59% age 21-64 years), Caucasian (41%), married/cohabitating (58%) and unemployed (55%). The number and types of symptom subgroups varied across these seven cancer populations: four-subgroups were the common in prostate, lung, non-Hodgkin's lymphoma, and breast cancer survivors. Unmarried, low education, and unemployment status were associated with high risk of symptom burden across the cancer types. CONCLUSION: Identifying symptom subgroups by cancer diagnosis has the potential to develop innovative and effective targeted interventions in cancer survivors. Further research is needed to establish extensive knowledge in symptom clustering between treatment regimens, and short-term and long-term cancer survivors.

Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients: a two-phase pilot study protocol.

Millions of family members and/or friends in the U.S. serve as unpaid caregivers for individuals with chronic conditions, such as cancer. Caregiving for someone undergoing an intense allogeneic hematopoietic stem cell transplant (HSCT) is particularly demanding, with accompanying physical and psychological stress. Increased stress and stress-related symptoms could make it difficult for caregivers to fulfill their roles and could negatively impact the health status and quality of life of themselves and the recipients. Virtual reality (VR) is a promising technology increasingly used for treatment and wellness in various medical settings. There is growing evidence that studies have reported the positive effects of the VR intervention in managing and reducing stress among diverse populations in various clinical scenarios; however, no published studies have focused on family caregivers of patients with cancer. The study aims to assess the feasibility and acceptability of a four-week nature-based VR intervention and to examine the effectiveness of the VR intervention on stress in HSCT caregivers. This study comprises two phases. Phase I of the study will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the VR intervention. Phase II of the study will be a prospective randomized controlled group design to examine the effectiveness of the VR intervention on perceived stress. Adults (≥ 18 years) who serve as primary caregivers for a person who will undergo an allogeneic HSCT will be recruited. Fifteen participants will be enrolled for Phase I and 94 participants for Phase II (Active VR arm N=47; Sham VR arm N=47). The nature-based immersive VR program contains 360° high-definition videos of nature scenes along with nature sounds through a head-mounted display (HMD) for 20 minutes every day for four weeks. Primary outcome is perceived stress measured by the Perceived Stress Scale. Secondary/exploratory outcomes are stress-related symptoms (e.g., fatigue, sleep disturbance) and physiological biomarkers (e.g., cortisol, alpha-amylase). The importance and innovativeness of this study consist of using a first-of-its-kind, immersive VR technology to target stress and investigating the health outcomes assessed by validated objective biomarkers as well as self-report measures of the nature-based intervention in the caregiver population. Clinical trial registration: ClinicalTrials.gov, identifier NCT05909202.

The Experience of Living With Polycystic Ovary Syndrome in the Military.

INTRODUCTION: Polycystic ovary syndrome (PCOS) is the most prevalent reproductive endocrinopathy in women, ranging from 5% to 26% depending on diagnostic criteria applied. Common manifestations of PCOS include overweight and obesity, abnormal menstrual cycles, pelvic pain, increased facial and body hair, acne, and infertility. These abnormalities and associated complications have significant military operational and readiness implications. There is a large gap in research regarding active duty servicewomen (ADW) with PCOS. Therefore, the purpose of this study is to describe ADW's experience of living with PCOS and to describe the service-branch-specific differences among these women. MATERIALS AND METHODS: Moderator's guide, audiotapes, transcripts, and field notes. This was a qualitative descriptive study using focus groups and individual interviews. The David Grant Medical Center Institutional Review Board at Travis AFB, CA, USA, approved the study protocol. Women with PCOS were recruited from U.S. Air Force, Army, and Navy locations. Data were analyzed using constant comparative content analysis. RESULTS: Twenty-three servicewomen from 19 occupations across the Army, Navy, Air Force, and Marine Corps participated. Three overarching categories emerged: (1) challenges managing PCOS symptoms, (2) navigating the military health care system, and (3) navigating PCOS as a service member. CONCLUSIONS: Servicewomen may have significant career consequences related to PCOS sequelae, such as overweight, obesity, uncontrolled menstrual cycle, and pain. Managing the myriad of symptoms can distract women while deployed, in austere conditions, or at their home stations. As one of the most common cardiometabolic, reproductive endocrinologic conditions in women, PCOS has not received the attention, awareness, education, or research necessary to sufficiently support ADW with this condition. It is imperative that evidence-based strategies are developed to inform relevant and high-quality care for these warfighters. Future qualitative studies are needed to further describe specific stressors and needs of ADW with PCOS. Future intervention studies are also needed to evaluate effective management options for ADW with PCOS.

Patterns of health-promoting behaviors and associated factors in family caregivers of people receiving cancer treatment: A latent class profile analysis.

OBJECTIVE: Family caregivers tend to neglect their health while prioritizing the needs of their care recipients. Identifying subgroups of caregivers based on the patterns of health-promoting behaviors (HPBs) may help develop tailored interventions for them, yet little is known. The purpose of this study was: (1) to identify latent classes with distinct patterns of HPBs in family caregivers of people with cancer; and (2) to investigate factors associated with the latent class membership. METHODS: We performed a cross-sectional data analysis using the baseline dataset from a longitudinal survey study that assessed HPBs of family caregivers of individuals who received cancer treatment at a national research hospital (N = 124). Latent class profile analysis was conducted to identify latent classes based on the subdomains of the Health-Promoting Lifestyle Profile II, followed by multinomial logistic regression analysis to investigate factors associated with the latent class membership. RESULTS: Three latent classes were identified: a high level of HPB (Class 1, 25.8%); a moderate level of HPB (Class 2, 53.2%); and a low level of HPB (Class 3, 21.0%) of HPBs. Controlling for caregiver age and sex, caregiver burden due to lack of family support, perceived stress, self-efficacy and body mass index were factors associated with the latent class membership. CONCLUSIONS: HPBs of our caregiver sample appeared in relatively stable patterns at different levels. Higher caregiver burden and perceived stress and lower self-efficacy were associated with the lower practice of HPBs overall. Our findings may serve as a reference for screening caregivers who need support and developing person-centered interventions.

Symptom Clusters in Family Caregivers of Hematopoietic Stem Cell Transplantation Recipients: Loneliness as a Risk Factor.

A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Family caregivers of allogeneic hematopoietic stem cell transplantation (HSCT) recipients experience multiple concurrent symptoms, but the majority of symptom research in this population has focused on assessing and managing individual symptoms. The purpose of this analysis was to determine (1) whether clusters of 5 highly prevalent symptoms (fatigue, sleep disturbance, depression, anxiety, and cognitive impairment) in allogeneic HSCT caregivers could be identified and (2) which caregiver and patient characteristics influence membership in the identified symptom cluster groups. Baseline cross-sectional data were collected from allogeneic HSCT caregivers participating in a randomized controlled trial at the National Institutes of Health Clinical Center. Measures included the Caregiver Reaction Assessment (CRA), Health-Promoting Lifestyle Profile II (HPLP-II), Fatigue Symptom Inventory (MFSI), Pittsburgh Sleep Quality Index (PSQI), and Patient-Reported Outcomes Measurement Information System (PROMIS). Cluster analysis was used to identify symptom clusters, and univariate analyses and multiple logistic regression were performed to identify factors that contribute to symptom clusters. The average age of caregivers (n = 44) was 45.20 ± 15.05 years; primarily white (52.3%) and female (88.6%) and often the spouse/partner of the patient (50.0%). Two symptom cluster groups were identified: low symptom burden (n = 24; 54.5%) and high symptom burden (n = 20; 45.5%). Caregivers with higher levels of loneliness (odds ratio, 1.12; 95% confidence interval, 1.04 to 1.22; P = .004) were more likely to be in the high symptom burden group. This study provides evidence that 5 symptoms commonly found in family caregivers-fatigue, sleep disturbance, depression, anxiety, and cognitive impairment-tend to occur in clusters. Therefore, clinicians should be aware that caregivers with 1 or more of these symptoms may be at higher risk for developing the others, and caregivers reporting high levels of loneliness may be at particular risk. Future research is needed to identify novel interventions that target multiple, co-occurring symptoms. Such interventions also might include components that decrease loneliness. © 2022 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.

Interleukin-8 (IL-8) as a Potential Mediator of an Association between Trimethylamine N-Oxide (TMAO) and Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) among African Americans at Risk of Cardiovascular Disease.

Trimethylamine N-oxide (TMAO)-a microbial metabolite derived from the hepatic-gut axis-is linked to inflammation, hyperlipidemia, and cardiovascular disease (CVD). Proprotein convertase subtilisin/kexin type 9 (PCSK9), which is largely hepatically expressed, blocks low-density lipoprotein (LDL) receptor recycling, also leading to hyperlipidemia. The primary objective of this study was to investigate a previously hypothesized potential relationship between TMAO and PCSK9 in order to explore novel mechanisms linking TMAO and CVD risk. African American adults at risk of CVD living in the Washington DC area were recruited to participate in a cross-sectional community-based study (n = 60, 93% female, BMI = 33). Fasting levels of inflammatory cytokines (i.e., interleukin (IL)-1 beta, tumor necrosis factor-alpha, and interleukin-8), TMAO, and PCSK9 were measured using Luminex and ELISA, respectively. Univariate and multivariate linear regression analyses and structural equation mediation analyses were conducted using STATA. All models were adjusted for body mass index (BMI) and atherosclerotic CVD risk score (ASCVD). A significant association between TMAO and PCSK9 was identified (ß = 0.31, p = 0.02). Both TMAO and PCSK9 were significantly associated with IL-8 (TMAO: ß = 0.45, p = 0.00; PCSK9: ß = 0.23, p = 0.05) in adjusted models. Mediation analysis indicated that 34.77% of the relationship between TMAO and PCSK9 was explained by IL-8. Our findings indicate a potential PCSK9-involved pathway for TMAO and CVD risk, with potential mediation by IL-8.

The role of the oral microbiome in smoking-related cardiovascular risk: a review of the literature exploring mechanisms and pathways.

Cardiovascular disease is a leading cause of morbidity and mortality. Oral health is associated with smoking and cardiovascular outcomes, but there are gaps in knowledge of many mechanisms connecting smoking to cardiovascular risk. Therefore, the aim of this review is to synthesize literature on smoking and the oral microbiome, and smoking and cardiovascular risk/disease, respectively. A secondary aim is to identify common associations between the oral microbiome and cardiovascular risk/disease to smoking, respectively, to identify potential shared oral microbiome-associated mechanisms. We identified several oral bacteria across varying studies that were associated with smoking. Atopobium, Gemella, Megasphaera, Mycoplasma, Porphyromonas, Prevotella, Rothia, Treponema, and Veillonella were increased, while Bergeyella, Haemophilus, Lautropia, and Neisseria were decreased in the oral microbiome of smokers versus non-smokers. Several bacteria that were increased in the oral microbiome of smokers were also positively associated with cardiovascular outcomes including Porphyromonas, Prevotella, Treponema, and Veillonella. We review possible mechanisms that may link the oral microbiome to smoking and cardiovascular risk including inflammation, modulation of amino acids and lipids, and nitric oxide modulation. Our hope is this review will inform future research targeting the microbiome and smoking-related cardiovascular disease so possible microbial targets for cardiovascular risk reduction can be identified.

Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancer caregivers: A randomized controlled trial.

Caregiving stress is a risk factor for cardiometabolic disease. Therefore, integrating cardiometabolic biomarkers into caregiving research provides a more comprehensive assessment of an individual's health and response to an intervention. The objective of this study was to examine the effects of a yoga-based stress reduction intervention on stress, psychological outcomes, and cardiometabolic biomarkers in cancer caregivers. This prospective randomized controlled trial enrolled family caregivers of adult patients who underwent an allogeneic HSCT at the National Institutes of Health (NIH) Clinical Center. All subjects received usual care education. Participants in the intervention group received an Iyengar yoga intervention self-administered over six weeks using an audio recording file. The primary outcome was perceived stress (measured using the NIH toolbox Perceived Stress). The secondary outcomes were psychological factors (depression and anxiety measured using PROMIS® Depression and Anxiety), and cardiometabolic biomarkers measured by nuclear magnetic resonance spectroscopy. A total of 50 family caregivers (mean [SD] age, 44.9 [15.2] years; 42 [84.0%] women) were randomized, 25 to the intervention group and 25 to the control group. No group differences were noted in stress, depression, and anxiety. Significant interaction effects between group and time were found in large TRL-P (F(1,43) = 10.16, p = 0.003) and LP-IR (F(1,42) = 4.28, p = 0.045). Post-hoc analyses revealed that the levels of large TRL-P (mean difference = 1.68, CI = [0.86, 2.51], p< .001) and LP-IR (mean difference = 5.67, CI = [1.15, 10.18], p = 0.015) significantly increased over time in the control group but while remained stable in the intervention group (mean difference = -0.15, CI = [-0.96, 0.66], p = 0.718; mean difference = -0.81, CI = [-5.22, 3.61], p = 0.714, respectively). Even when perceptions of psychological distress remain unchanged, incorporating gentle yoga poses and breathing exercises may reduce the risk of cardiometabolic disease in caregivers by inhibiting the development of insulin resistance. Standard lipids of cardiometabolic risk do not appear to be robust enough to detect short-term early changes of cardiometabolic risk in caregivers. Trial registration: ClinicalTrials.gov Identifier: NCT02257853.

Experiences of Patients After Withdrawal From Cancer Clinical Trials.

Importance: Cancer clinical trials (CCTs) provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remission. For some, a CCT may seem like their only option. Little is known about experiences of patient-participants who withdraw or are withdrawn from CCTs. Objective: To examine patient-participants' experiences during withdrawal from CCTs. Design, Setting, and Participants: This qualitative, descriptive study used a semistructured interview designed specifically for it, with open-ended and probing questions. The study took place at a National Cancer Institute-designated comprehensive cancer center affiliated with the University of Pennsylvania. The need for a sample of 20 interviewees was determined by code and meaning saturation (ie, no new themes revealed and identified themes fully elaborated). Interviews were transcribed verbatim and analyzed with a qualitative software program. Data coded with the software were refined into categories reflecting broad themes. A criterion-based sampling approach was used to select a subset of adult patients with cancer who were former CCT participants and who agreed on exit from those CCTs to a later interview about withdrawal experiences. They were contacted one by one by telephone from September 2015 through June 2019 until 20 agreed. Data analysis was completed in October 2020. Main Outcomes and Measures: Themes characterizing patient-participants' perceptions of their withdrawal experiences. Results: Respondents' mean (SD) age was 64.42 (8.49) years; 12 (63.2%) were men. Most respondents were White (18 respondents [94.7%]) and college educated (11 respondents [55.0%]). Cancer stage data were available for 17 participants, 11 of whom (64.7%) had stage IV cancer at CCT enrollment. Thirteen respondents reported withdrawal as a result of disease progression, and 5 withdrew because of adverse effects. Other reasons for withdrawal included acute illness and participant uncertainty about the reason. Analysis of interview data yielded 5 themes: posttrial prognostic awareness, goals of care discussions, emotional coping, burden of adverse effects, and professional trust and support. Subthemes included regrets or hindsight, urgency to start next treatment, and weighing benefits and burdens of treatment. Limited discussions about patient-participants' immediate posttrial care needs left many feeling that there was no clear path forward. Conclusions and Relevance: Patient-participants transitioning from a CCT described feeling intense symptoms and emotions and awareness that their life span was short and options seemed to be limited. Communication that includes attention to posttrial needs is needed throughout the CCT to help patient-participants navigate posttrial steps. Research should focus on components of responsible and ethical CCT transitions, including types and timing of discussions and who should begin these discussions with patient-participants and their families.

Symptom Clusters and Influencing Factors in Family Caregivers of Individuals With Cancer.

BACKGROUND: A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Although family caregivers of individuals with cancer experience multiple concurrent symptoms, the majority of symptom research has focused on assessing and managing individual, isolated symptoms. OBJECTIVE: The study purpose was to investigate symptom clusters in cancer caregivers and to explore factors that influence symptom clusters. METHODS: Cluster analysis was performed using cross-sectional survey data from 129 family caregivers of individuals receiving cancer treatment at the National Institutes of Health Clinical Center. PROMIS (Patient-Reported Outcomes Measurement Information System) measures of 5 common symptoms in caregivers (fatigue, sleep disturbance, depression, anxiety, impaired cognition) were used to identify symptom clusters. RESULTS: Two symptom cluster groups were identified: low symptom burden (n = 106, 82.2%) and high symptom burden (n = 23, 17.8%). Individuals who reported higher levels of caregiving burden (impact on health subscale) (ß = 1.31, P = .005) and loneliness (ß = 0.18, P = .024) were significantly more likely to be in the high symptom burden group. CONCLUSIONS: This study provides evidence that 5 key symptoms among cancer caregivers appear to cluster into 2 groups, those with low symptom burden and those with high symptom burden. Caregiving burden (impact of health) and loneliness were significant factors differentiating symptom cluster membership. IMPLICATIONS FOR PRACTICE: Identifying symptom clusters may lead to better prevention and treatment strategies that target symptoms in cancer caregivers. Identifying factors that place a group at high risk of symptom burden can be used to guide individualized and tailored interventions.

Time to listen: a mixed-method study examining community-based views of mobile technology for interventions to promote physical activity.

INTRODUCTION: A mixed-method, co-design approach to studying the adoption of mobile health (mHealth) technology among African-American (AA) women has not been fully explored. Qualitative data may contextualise existing knowledge surrounding perceptions of mHealth among AA women as part of formative work for designing a physical activity application (app). METHODS: A convenience sample of 16 AA women completed an informatics survey prior to participating in focus groups exploring their use of mobile technology and health apps. Survey responses provided frequency data, while iterative transcript analysis of focus groups identified themes. RESULTS: The majority of participants (mean age=62.1 years, SD=6.6) felt comfortable using a tablet/smartphone (75.0%). Most (68.8%) reported using health-related apps, primarily focused on physical activity and nutrition. Focus groups revealed four overarching concepts, including (1) user attachment, (2) technology adoption, (3) potential facilitators and (4) potential barriers. Important features which may serve as facilitators or barriers to future adoption of a mobile app for an mHealth intervention include individual app tailoring and software concerns, respectively. DISCUSSION: Thematic analysis revealed high user attachment to smartphones and described participants' process for adopting new mHealth technology. CONCLUSION: Early engagement of target end users as a part of a broader co-design and community-based participatory research process for developing mHealth technologies may be useful for sustained adoption of these tools in future mHealth behavioural interventions.

Factors influencing loneliness in cancer caregivers: A longitudinal study.

OBJECTIVE: To describe levels of loneliness in cancer caregivers over a 6 month time period, and to examine factors that influence changes in loneliness in caregivers over time. METHODS: Prospective, repeated measures design was utilized to examine levels of loneliness and factors that influence loneliness in 129 family caregivers of individuals undergoing cancer treatment at three time points over a 6 month period. Measures included: PROMIS global health and sleep disturbance; NIH Toolbox loneliness, self-efficacy and perceived stress; Family Care Inventory mutuality scale; and Caregiver Reaction Assessment. RESULTS: Approximately one third (30.2%, n = 39) of the caregivers had high levels of loneliness, and levels of loneliness did not change over the three time points (P = .985). For any given time point, caregivers who were not married (P = .008), not working (P = .027), with worse mental health (P = .015), more perceived-stress (P < .0001), and more caregiver burden (P = .003) reported higher levels of loneliness. CONCLUSION: This study provides guidance for clinicians attempting to identify at-risk caregivers by confirming the findings of previous research that caregivers with higher burden, stress and in poor mental health are at increased risk for loneliness. This study provides preliminary evidence that continuing to work during the caregiving trajectory may be beneficial to caregivers by reducing levels of loneliness. Future research is needed to confirm these findings and to examine novel interventions to reduce loneliness in cancer caregivers.

Symptom Clusters in Breast Cancer Survivors: A Latent Class Profile Analysis.

OBJECTIVES: To identify symptom clusters in breast cancer survivors and to determine sociodemographic and clinical characteristics influencing symptom cluster membership. SAMPLE AND SETTING: The authors performed a cross-sectional secondary analysis of data obtained from a community-based cancer registry-linked survey with 1,500 breast cancer survivors 6-13 months following a breast cancer diagnosis. METHODS AND VARIABLES: Symptom clusters were identified using latent class profile analysis of four patient-reported symptoms (pain, fatigue, sleep disturbance, and depression) with custom PROMIS® short forms. RESULTS: Four distinct classes were identified. IMPLICATIONS FOR NURSING: Common symptom clusters may lead to better prevention and treatment strategies that target a group of symptoms. Results also suggest that certain factors place patients at high risk for symptom burden, which can guide tailored interventions.

Integrating Genomics into Oncology Practice.

OBJECTIVE: To discuss our clinical research hospital's experience in integrating genomics into nursing practice. DATA SOURCES: Published literature, national guidelines, and Web sites. CONCLUSION: Utilizing a program based on the Method for Introducing a New Competency toolkit and adapted competencies from the Essentials of Genetic and Genomic Nursing, the National Institutes of Health Clinical Center successfully integrated genomics into nursing practice and all major educational programs. IMPLICATIONS FOR NURSING PRACTICE: This experience provides an example for other nurses to integrate genetics/genomics into their practice settings.

Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer Clinical Trial Participation.

We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative ( n = 32) and quantitative sample ( n = 110) of cancer clinical trial participants. Benefit-burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (α = .90) and Burden (α = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores ( p < .001) and higher Burden scores ( p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research.

Apoptotic Activities of Sanguinaria canadensis: Primary Human Keratinocytes, C-33A, and Human Papillomavirus HeLa Cervical Cancer Lines.

BACKGROUND: Sanguinarine is a benzophenanthridine alkaloid derived from the root of Sanguinaria canadensis. Multiple published, preclinical studies have demonstrated that sanguinarine causes apoptosis in human cancer cells. An expert panel of naturopathic doctors identified sanguinarine as a component for consideration in cervical atypia management protocols. Clinical studies have identified positive outcomes when Sanguinaria is a constituent of escharotic treatment in cervical atypia management protocols. Therefore, further investigation and development of sanguinarine as a potential cancer treatment is recommended. Thus, the aim of this study is to further elucidate the signaling pathways of sanguinarine-induced cell death. METHODS: Cell cultures of cervical cancer line C-33A (human papillomavirus [HPV] negative), HeLa (HPV positive), and normal primary human keratinocytes were established. Microscopic plate inspection, cell viability, initiator and effector caspase assays were completed in triplicate on C-33A (HPV negative), HeLa (HPV positive), and normal primary human keratinocytes cells exposed to incremental doses of sanguinarine. RESULTS: Sanguinarine induced dose-dependent cell death in cervical cancer lines as well as in normal human keratinocytes. Microscopic plate inspection confirmed morphologic changes of cell death in normal keratinocytes, C-33A, and HeLa including cell shrinkage, round up, and detachment from plate surface. Caspase assays demonstrated that sanguinarine treatment of C-33A cells resulted in an induction of caspase-3/7 when compared with vehicle-treated controls. CONCLUSIONS: Sanguinarine demonstrates potential as an agent with therapeutic impact because of the capacity to eliminate cancerous cells through apoptosis, the process of programed cell death. Further elucidation of signaling pathways of sanguinarine-induced cell death is necessary when considering sanguinarine as a treatment for cervical cancer.

Documenting stress in caregivers of transplantation patients: initial evidence of HPA dysregulation.

There is growing evidence linking caregiver stress with an increased risk for morbidity and mortality. While the emotional and practical burden experienced by caregivers is well established, the physiological changes that may affect the caregiver's health are less understood. This study sought to compare self-reported stress, anxiety and depression along with neuroendocrine and immune markers of stress among adult caregivers of allogeneic hematopoietic stem cell transplantation patients during the acute transplant recovery period to matched non-caregivers controls. Biomarkers and self-reported data were collected at three points during the patient's HSCT: (1) before transplant, (2) after initial transplantation discharge (±7 days) and (3) 6 weeks after initial transplantation discharge. Mixed linear modeling was used to examine differences by group and time. Twenty-one caregivers and 20 controls completed all study procedures. The majority of caregivers were female (57% or 57.1%) and married (95.2%), with a mean age of 52 ± 11.4 years. Caregiver perceived stress, anxiety and depression scores were significantly higher than controls (p < 0.001) with effect sizes (ES) ranging from 1.37 to 1.80 and they did not change over time (p > 0.05) for either group. Caregivers had significantly lower serum cortisol levels than controls at both discharge (p = 0.013; ES = 0.81) and 6 weeks after discharge (p = 0.028; ES = 0.72) but exhibited no significant relationship between self-reported stress and serum cortisol. In addition, caregivers showed a significant inverse relationship between stress and epinephrine levels (r(s)=-0.654, p = 0.021). These findings support the evidence of the caregiving experience being stressful. The counter-intuitive relationship between cortisol and epinephrine might suggest dysregulation of the HPA axis and central nervous system but additional research on the physiological impact of caregiving is warranted.

Cancer clinical trial participants' assessment of risk and benefit.

BACKGROUND: The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment. METHODS: One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials. RESULTS: Of the participants, 51.6% reported they did not directly assess the benefits or risks. Educational level, age, employment, treatment options, insurance, and spiritual-religious beliefs were significantly associated with whether participants assessed risk and benefits. Those who felt well informed were more likely to have assessed the benefits and risks at enrollment than those who did not feel well informed (odds ratio [OR] = 3.92, p = .014); of those who did not assess the risks and benefits, 21% did not feel well informed at enrollment (p = .001). Those who agreed that the clinical trial helped pay the costs of the care had nearly three times the odds of not assessing risks and benefits compared to those who disagreed. CONCLUSION: Our findings have important implications for understanding the role of assessing risks and benefits in the research participation decisions of patients with cancer and call for further understanding of why participants are not assessing information believed to be essential for autonomous informed decisions.

Health-promoting lifestyles and depression in urban elderly Chinese.

OBJECTIVE: To explore health-promoting lifestyles, depression and provide further insight into the relationship between health-promoting lifestyles and depression in an urban community sample of elderly Chinese people. METHODS: A cross-sectional descriptive and correlational study of 954 community-dwelling urban elderly Chinese (aged ≥ 60) was conducted from July to December 2010. Lifestyles and depression were assessed using the revised Chinese Version of the Health-Promoting Lifestyle Profile (HPLP-C) and the Geriatric Depression Scale (GDS), respectively. RESULTS: In this cohort, 15.8% of elderly urban adults met the criteria for depression. Over half of the sample (62.1%) scored greater than 100 on the HPLP-C, with range of score sum from 55 to 160. There were significant correlations between self-actualization (OR = 1.167, 95%CI: 1.111-1.226), nutrition (OR = 1.118, 95%CI: 1.033-1.209), physical activity (OR = 1.111, 95%CI: 1.015-1.216) and depression among community-dwelling elderly Chinese. LIMITATIONS: This was a cross-sectional study. The significant associations found do not represent directional causation. Further longitudinal follow-up is recommended to investigate the specific causal relationship between lifestyles and depression. CONCLUSIONS: Depression was common with medium to high levels of health-promoting lifestyles among urban elderly Chinese people. Lifestyle behaviors such as self-actualization, good nutrition habits and frequent physical activity were correlated to fewer depressive symptoms. Healthy lifestyles should be further developed in this population and measures should be taken for improving their depression.