Topical Cannabidiol for Established Chemotherapy-Induced Neuropathy: A Pilot Randomized Placebo-Controlled Trial.

Background: Patients have been known to use cannabinoids for treating established chemotherapy-induced peripheral neuropathy (CIPN) based on anecdotal information and retrospective reports suggesting that such might be beneficial. In response, a double-blinded, placebo-controlled, randomized, pilot clinical trial was developed to evaluate whether resultant data would support a phase III trial for testing whether a cannabidiol (CBD) cream might improve CIPN. Methods: Forty patients with established CIPN were randomized, in a double-blinded manner, to topical CBD or a placebo cream. The study product was applied for 2 weeks, followed by a crossover for 2 weeks. Neuropathy was evaluated using the European Organization of Research and Treatment of Cancer (EORTC)-CIPN20, the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, and the Global Impression of Change instruments. Side effects were recorded by symptom diaries. Results: The EORTC-CIPN20 scores were similar in the patients receiving CBD versus the placebo. Likewise, the toxicity scores were similar in patients who received the CBD versus the placebo. Conclusions: This pilot trial did not support that the studied CBD isolate cream improved painful established CIPN. It was well tolerated overall. Clinical Trial Registration Number: NCT05388058.

Higher Levels of Stress and Neuropsychological Symptoms Are Associated With a High Nausea Profile in Patients With Cancer Receiving Chemotherapy.

OBJECTIVES: To evaluate differences in the severity of global, cancer-specific, and cumulative life stress, resilience, and common neuropsychological symptoms among four subgroups of patients with distinct chemotherapy-induced nausea (CIN) profiles. SAMPLE & SETTING: Adult patients with cancer (N = 1,343) receiving chemotherapy. METHODS & VARIABLES: Patients completed stress, resilience, and neuropsychological symptom severity measures. The Memorial Symptom Assessment Scale was used to assess CIN occurrence six times over two cycles of chemotherapy. Parametric and nonparametric statistics were used to evaluate differences among subgroups of patients with distinct CIN profiles. RESULTS: The high class had significantly higher levels of global, cancer-specific, and cumulative life stress; significantly higher levels of depression, anxiety, sleep disturbance, morning and evening fatigue, and pain; and lower levels of morning and evening energy and cognitive dysfunction. IMPLICATIONS FOR NURSING: Clinicians need to evaluate CIN occurrence across each cycle of chemotherapy and assess patients for various types of stress and common neuropsychological symptoms.

Quality of Life of Older Adults With Complicated Grief: A Mixed Methods Exploration.

The current mixed methods study investigated what changes in quality of life (QOL) mean to older adults with complicated grief treated with Accelerated Resolution Therapy (ART) post-hospice services. An informational matrix, which included select patient characteristics (e.g., number of comorbidities, single versus multiple deaths, relationship role), four identified qualitative themes, end of study QOL scores measured by the Centers for Disease Control and Prevention Health-Related QOL Healthy Days Module, and changes in scores from baseline to end of study, was created to analyze the data. Results showed that although a history of multiple deaths may contribute to greater improvements in QOL with therapy, having at least one comorbidity resulted in a richer description and endorsement of QOL in response to treatment. This is the first longitudinal, randomized controlled trial using a mixed methods approach to examine QOL of hospice family caregivers with complicated grief who are receiving ART. This study identifies potential links of QOL and caregiver characteristics, providing nurses with foundational knowledge for assessment, care, and further research on the experiences of complicated grief. [Journal of Gerontological Nursing, 48(5), 19-26.].

A Longitudinal Examination of Quality of Life of Older Adults with Complicated Grief Receiving Accelerated Resolution Therapy.

Objective: To examine the effect of Accelerated Resolution Therapy (ART) on the quality of life (QOL) of older adults with complicated grief (CG) over time. Design: Subanalysis of a randomized controlled trial. Setting/Subject: Older adult, former caregivers were recruited from a large hospice in the southeastern United States to be treated with ART for CG. Measurement: The CDC Health-Related Quality of Life (HRQOL) Healthy Days Module was administered pre-, post-, and eight weeks after therapy. Results: The subsample consisted of 27 older adults. A multilevel model indicated a statistically significant, negative difference of 8.21 (improvement) in QOL scores for each period of data collection (ß = -8.21, t = 4.02, p < 0.001). Both the intervention (11%, p = 0.013) and time (7.8%, growth curve p = 0.014) contributed significantly. Conclusion: There was a significant large effect of ART on CG. This study supports concurrent improved patient-related outcome-QOL.

Quality of life of older adults with complicated grief: A thematic analysis.

Approximately 15% of the general population has complicated grief (CG). Understanding how older adults with CG describe their quality of life (QOL) is crucial to healthcare workers especially in hospice and mental health settings. Four themes for QOL emerged from the thematic analysis of semi-structured interviews. From highest to lowest endorsement, they were Mental Function (sub-themes: mental health, joy, and happiness), Self-management (sub-themes: self-efficacy and self-agency), Social Support, and Physical Function. This study provides new information related to the relationships between CG and QOL among older adults. Multidimensional aspects of QOL can provide insight into delivering individualized patient- and family-centered care.

Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity.

Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.

Challenges in Obtaining and Assessing Salivary Cortisol and α-Amylase in an Over 60 Population Undergoing Psychotherapeutic Treatment for Complicated Grief: Lessons Learned.

Biomarkers may serve as objective measures in complicated grief (CG) potentially capturing responses to stress reduction treatment. This paper reports challenges in obtaining and assessing salivary cortisol and α-amylase (sAA) for a recent randomized clinical trial. Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale. Bivariate correlations and multiple regressions examined changes in biomarkers. Protocols, study logs, and audit reports identified challenges. Challenges included obtaining unstimulated passive drool salivary samples and their analyses. Our sample of older females on multiple medications may have resulted in a perfect storm of moderating and intervening variables which affected the stress response. This paper contributes to the discussion on designing clinical trials for older adults which must account for physiologic changes, multimorbidity, and polypharmacy common in this population and makes recommendations moving forward.

The Physical Consequences of Chemotherapy-Induced Peripheral Neuropathy.

PURPOSE OF REVIEW: Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of numerous chemotherapy drugs. CIPN negatively impacts function and quality of life during and after treatment. We will provide a review of the data describing the physical consequences of CIPN and discuss the possible long term impact on emotional well-being and quality of life. RECENT FINDINGS: CIPN negatively affects physical function and many aspects of quality of life. Exercise interventions are likely to reduce the risk of falls associated with CIPN. There remains a need for evidence-based interventions focused on improving symptoms, function, and quality of life in persons with CIPN.

Complicated Grief: Risk Factors, Protective Factors, and Interventions.

Complicated grief (CG) poses significant physical, psychological, and economic risks to bereaved family caregivers. An integrative review of the literature published 2009-2018 on CG associated with caregiving was performed using PubMed, PsychINFO, and Web of Science. The search returned 1428 articles, of which 32 were included in the review. Sixteen studies described risk and protective factors and 16 described interventions for CG. Caregiver-related risk factors included fewer years of education, depression, anxiety, poor physical health, and maladaptive dependency and attachment traits. Additional risk factors included lower perceived social support, family conflict at end-of-life, and family having difficulty accepting death. Care recipient-related risk factors are younger age, fear of death, and place of death. Protective factors included hospice utilization in reducing fear of death, high pre-bereavement spiritualty, and satisfaction with palliative care. Complicated grief treatment was the most widely-studied intervention. Social Workers and other clinicians can use this information to identify family caregivers at increased risk for CG and refer or implement an early intervention to lessen its impact.

Understanding the roles of patient symptoms and subjective appraisals in well-being among breast cancer patients.

PURPOSE: To examine the roles of both patient symptoms, and subjective appraisals of stress (self-efficacy, symptom barriers, symptom distress), in understanding well-being (anxiety, depression, cancer-specific quality of life, mental health quality of life, and physical health quality of life) in breast cancer patients. METHODS: We examined data from 104 female breast cancer patients. Using a stress process model, we hypothesized that while high levels of patient symptoms would be associated with poorer patient well-being, these effects would be mediated by subjective appraisals, including patient self-efficacy, perceived symptom barriers, and symptom distress. RESULTS: As expected, higher levels of patient symptoms were associated with poorer well-being on all five indicators. Subjective appraisals of stress added significantly to predictors of well-being, and were mediators of this relationship across all five outcomes. CONCLUSIONS: While patient symptoms are important predictors of patient well-being, subjective appraisals of the stressfulness of symptoms, and of patients' self-efficacy in managing symptoms, are also key factors. The findings suggest the utility of a stress process model in understanding well-being in breast cancer patients, and point to the potential value of targeting patient appraisals as well as symptoms to improve psychological well-being and quality of life.

Complicated Grief of Immediate Family Caregivers: A Concept Analysis.

Grieving is a normal reaction to loss; however, not everyone is able to recover from grief and adjust to a life after the loss. "Complicated grief" (CG) is a term used to describe intense and prolonged bereavement after the loss of a loved one that interferes with normal activities accompanied by destructive thoughts and behaviors. In practice and research, the concept of CG varies in definition and instruments used to measure. This concept analysis examines relevant research related to CG experienced by caregivers to provide a clear, comprehensive definition. Implications for nursing practice and research are explored.

Differences in fatigue severity in a sample of adult cancer patients.

AIMS AND OBJECTIVES: To describe differences in fatigue severity in a sample of adult Puerto Rican patients during and postcancer treatments. BACKGROUND: Hispanics, including Puerto Ricans, are an understudied population who are under-represented in clinical trials, especially in symptom research. Although symptom management is a clinical priority in oncology care, treatment-related differences in Puerto Rican cancer patients' report of fatigue severity have not been well described. DESIGN/METHODS: A cross-sectional survey was conducted from data of self-report of 138 Puerto Rican patients during and postcancer treatments at two ambulatory facilities located in San Juan, Puerto Rico. Fatigue severity was assessed using the Fatigue subscale from the Functional Assessment of Cancer Therapy-Fatigue quality of life questionnaire Spanish version. Differences in fatigue severity across type of treatment (radiation therapy, chemotherapy, combined radiation chemotherapy and post-treatment) were evaluated using nonparametric (Kruskal-Wallis and Mann-Whitney test) statistical tests. RESULTS: The majority of the participants had prostate (33%) and breast (32%) cancers and were receiving radiation therapy (43%) or chemotherapy (28%). The Kruskal-Wallis test showed that there was a statistically significant difference in fatigue scores between the different four treatment conditions, χ2 (3) = 39.1, p = .001 with patients on combined radiation chemotherapy or chemotherapy alone experiencing more severe fatigue. CONCLUSIONS: Findings from the current study suggest that type of treatment is a key component of the symptom burden of fatigue among the Puerto Rican oncology population. Specially, patients receiving combined therapy or chemotherapy alone were at increased risk for experiencing severe fatigue, compared to radiation therapy and post-treatment patients. RELEVANCE TO CLINICAL PRACTICE: With the worldwide increase in migration of Puerto Rican families, nurses need to recognise that type of treatment is a key component of the symptom burden of fatigue among the Puerto Rican population. The results of this study will improve understanding of treatment-related fatigue to identify therapeutic targets and improve quality of life of patients.

Complicated Grief: Risk Factors, Interventions, and Resources for Oncology Nurses.

BACKGROUND: When a loved one dies of cancer, complicated grief (CG) may occur because of the trauma associated with family caregivers' perceptions of their loved one's suffering, either from advanced cancer or from side effects of cancer treatment.
. OBJECTIVES: This article provides an overview of CG and existing interventions for family caregivers who may be at risk for CG following the loss of a loved one and the implications for oncology nurses who provide emotional support and guidance.
. METHODS: Current evidence related to the treatment of CG and information to assist with identification of individuals at risk for CG are presented, as well as resources for oncology nurses who encounter individuals who are at high risk for, or who are experiencing, CG.
. FINDINGS: Although therapy interventions for CG have been shown to be effective forms of treatment, these therapies are not widely available and often require an extended treatment period to yield results. Oncology nurses can provide early interventions, such as referrals to supportive care services and mental health professionals to facilitate effective treatment.

Opioid-Induced Hyperalgesia: Clinical Implications for Advanced Practice Nurses in Oncology.

Opioid-induced hyperalgesia (OIH) is a key factor in the clinical management of patients experiencing pain. However, limited knowledge exists regarding the specific mechanisms involved in OIH and its treatment. A thorough assessment is usually required, and clinical diagnosis is mainly determined by exclusion in medical practice. Patients who are taking opioids should receive ongoing, comprehensive assessment by a clinician. Early identification of OIH will lead to improved patient outcomes.
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Body Image in Younger Breast Cancer Survivors: A Systematic Review.

BACKGROUND: Body image is a complex issue with the potential to impact many aspects of cancer survivorship, particularly for the younger breast cancer survivor. OBJECTIVE: The purpose of this review is to synthesize the current state of the science for body image in younger women with breast cancer. METHODS: Combinations of the terms "body image," "sexuality intervention," "women," "younger women," and "breast cancer" were searched in the PubMed, PsycINFO, CINAHL, Web of Knowledge, and Science Direct databases through January 2014. Inclusion criteria for this review were (1) original research, (2) published in English from the year 2000 forward, (3) measuring body image as an outcome variable, and (4) results included reporting of age-related outcomes. RESULTS: Thirty-six articles met the inclusion criteria. The majority of studies were cross-sectional, with extensive variation in body image assessment tools. Age and treatment type had a significant impact on body image, and poorer body image was related to physical and psychological distress, sex and intimacy, and the partnered relationship among younger women. Only 1 intervention study found a significant improvement in body image after intervention. CONCLUSIONS: Findings suggest body image is a complex posttreatment concern for breast cancer survivors, particularly younger women. The findings of this review are limited by the high level of variation in the methods for assessing body image. IMPLICATIONS FOR PRACTICE: Further research of interventions to address body image concerns following treatment for breast cancer is warranted. Improvement of body image may improve the quality of life of younger breast cancer survivors.

Development and psychometric evaluation of the chemotherapy-induced peripheral neuropathy assessment tool.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) can be a debilitating and dose-limiting adverse effect of chemotherapy. Comprehensive self-report tools for CIPN are needed for research and clinical practice. OBJECTIVE: The purpose of this psychometric study was to describe the development and evaluate the reliability and validity of a new self-report tool designed to measure CIPN, the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT). METHODS: One hundred sixty-seven patients receiving outpatient chemotherapy with paclitaxel, docetaxel, cisplatin, or oxaliplatin completed the CIPNAT. Content validity, convergent validity, discriminant validity, test-retest reliability, and internal consistency reliability were assessed. RESULTS: Content validity index was very acceptable at 0.95. Convergent validity data were provided by correlation with a measure of the same concept (r = 0.83, P < .001), and differences between contrasting groups (t = 7.66, P < .001) provided evidence of discriminant validity. High test-retest correlations (r = 0.92, P < .001), Cronbach α (α = .95), and significant item-to-total correlations ranging from 0.38 to 0.70 provided evidence of reliability. CONCLUSIONS: Results provide evidence of the validity and reliability of the CIPNAT, which can be used for comprehensive assessment of CIPN. IMPLICATIONS FOR PRACTICE: Use of the CIPNAT in research may lead to a better understanding of CIPN and guide nurses in developing and testing of interventions to relieve suffering and enhance quality of life for patients with CIPN.

Pain, neuropathic symptoms, and physical and mental well-being in persons with cancer.

BACKGROUND: Neuropathic pain is present in at least 25-40% of people with cancer pain and is thought to be more difficult to control than other types of cancer related pain. OBJECTIVE: The purpose of this study was to explore differences in the experience of cancer patients who describe their pain using neuropathic descriptors compared to those who do not. METHODS: A secondary analysis of data from 234 outpatients from a large NCI designated cancer center in west, central Florida was conducted to identify differences in pain, pain interference, symptoms, health related quality of life, and depression between the two groups. RESULTS: Patients with numbness, tingling, or electric-like sensations reported higher levels of current pain (p= .001), pain at its worst (p= .001), pain on average (p= .019), pain at its least (p= .008), and pain interference (p< .001). They reported problems with dizziness/lightheadedness significantly more often (p=.004) and also reported more severe problems with concentration (p=.047), poorer physical (p=.019) and mental health (p=.024), although no differences in depressive symptoms were found. CONCLUSIONS: The results of this study indicate that cancer patients with numbness, tingling, or electric-like sensations have significantly higher levels of pain and pain interference, and lower health related quality of life than do patients without these symptoms. IMPLICATIONS FOR PRACTICE: These results highlight the ongoing need for research evaluating methods of treating neuropathic pain; education regarding assessment and management of neuropathic pain; and aggressive efforts to relieve neuropathic pain in oncology settings.