Costs of Cancer Prevention: Physical and Psychosocial Sequelae of Risk-Reducing Total Gastrectomy.

PURPOSE: Risk-reducing surgery for cancer prevention in solid tumors is a pressing clinical topic because of the increasing availability of germline genetic testing. We examined the short- and long-term outcomes of risk-reducing total gastrectomy (RRTG) and its lesser-known impacts on health-related quality of life (QOL) in individuals with hereditary diffuse gastric cancer syndrome. METHODS: Individuals who underwent RRTG as part of a single-institution natural history study of hereditary gastric cancers were examined. Clinicopathologic details, acute and chronic operative morbidity, and health-related QOL were assessed. Validated questionnaires were used to determine QOL scores and psycho-social-spiritual measures of healing. RESULTS: One hundred twenty-six individuals underwent RRTG because of a pathogenic or likely pathogenic germline CDH1 variant between October 2017 and December 2021. Most patients (87.3%; 110/126) had pT1aN0 gastric carcinoma with signet ring cell features on final pathology. Acute (<30 days) postoperative major morbidity was low (5.6%; 7/126) and nearly all patients (98.4%) lost weight after total gastrectomy. At 2 years after gastrectomy, 94% (64/68) of patients exhibited at least one chronic complication (ie, bile reflux, dysphagia, and micronutrient deficiency). Occupation change (23.5%), divorce (3%), and alcohol dependence (1.5%) were life-altering consequences attributed to total gastrectomy by some patients. In patients with a median follow-up of 24 months, QOL scores decreased at 1 month after gastrectomy and returned to baseline by 6-12 months. CONCLUSION: RRTG is associated with life-changing adverse events that should be discussed when counseling patients with CDH1 variants about gastric cancer prevention. The risks of cancer-prevention surgery should not only be judged in the context of likelihood of death due to disease if left untreated, but also based on the real consequences of organ removal.

Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling.

New medicines containing classic hallucinogenic and entactogenic psychedelic substance are under development for various psychiatric and neurological disorders. Many of these, including psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are Schedule I controlled substances of the United States Controlled Substances Act (US CSA), and similarly controlled globally. The implications of the CSA for research and medicines development, the path to approval of medicines, and their subsequent removal from Schedule I in the US are discussed. This entire process occurs within the framework of the CSA in the US and its counterparts internationally in accordance with international drug control treaties. Abuse potential related research in the US informs the eight factors of the CSA which provide the basis for rescheduling actions that must occur upon approval of a drug that contains a Schedule I substance. Abuse-related research also informs drug product labeling and the risk evaluation and mitigation strategies (REMS) will likely be required for approved medicines. Human abuse potential studies typically employed in CNS drug development may be problematic for substances with strong hallucinogenic effects such as psilocybin, and alternative strategies are discussed. Implications for research, medicinal development, and controlled substance scheduling are presented in the context of the US CSA and FDA requirements with implications for global regulation. We also discuss how abuse-related research can contribute to understanding mechanisms of action and therapeutic effects as well as the totality of the effects of the drugs on the brain, behavior, mood, and the constructs of spirituality and consciousness.

Integrating geriatric assessment and genetic profiling to personalize therapy selection in older adults with acute myeloid leukemia.

INTRODUCTION: Survival benefit associated with intensive over low-intensity chemotherapy in older adults with acute myeloid leukemia (AML) is controversial. Geriatric assessment and genetic risk categories correlate with survival following intensive chemotherapy in older adults with AML and can guide treatment selection. MATERIALS AND METHODS: In a single-center trial, we integrated both geriatric assessment, and genetic risk categories to personalize selection of intensive versus low-intensity chemotherapy in older adults ≥60 years with AML (NCT03226418). In the present report, we demonstrate feasibility of this approach. RESULTS: Broad eligibility criteria and co-management of patients with community oncologists allowed enrollment of 45% of all patients with AML treated at our center during the study period. The median time from enrollment to therapy initiation was two days (range 0-9). Over half of the trial patients had a score of ≥3 on hematopoietic cell transplantation comorbidity index, impairment in physical function (Short Physical Performance Battery), and Montreal Cognitive Assessment. Three fit patients received intensive chemotherapy, whereas other patients received low-intensity chemotherapy. Mortality at 30 days from diagnosis was 3.7% (95% confidence interval [CI] 0.7-18.3%) and at 90 days was 29.6% (95% CI 15.9-48.5%). One-year overall survival was 66% (95% CI 60-87%). DISCUSSION: Our data demonstrate the feasibility of integrating geriatric assessment in precision oncology trials to define fitness for intensive chemotherapy. Broad eligibility criteria and academic-community collaboration can expand access to clinical trials.

Cancer-related fatigue and sleep deficiency in cancer care continuum: concepts, assessment, clusters, and management.

Throughout the cancer continuum, patients are faced with the cancer- and treatment-related side effects that can have a negative impact on their overall quality of life. Cancer-related fatigue (CRF) and sleep deficiency are among the symptoms that patients and their caregivers most often experience. An increasing body of literature suggests that a strong correlation between CRF and sleep deficiency exists, indicating that they may be reciprocally related and that they may have similar underlying etiology. This paper aims at bringing together the opinions of leading cancer control (i.e., CRF and sleep) and oncology experts in order to increase the understanding of CRF and sleep deficiency's assessment, associated symptom clustering, symptom burden shared by caregivers, and CRF and sleep deficiency management in the cancer care context.

Life perceptions of patients receiving palliative care and experiencing psycho-social-spiritual healing.

BACKGROUND: It is important to identify, from the patients' perspectives, the different factors that contribute toward psycho-social-spiritual healing. METHODS: This was a qualitative study that took place at a large research center, an underserved clinic, and a community hospital. We used a needs assessment questionnaire and open-ended questions to assess the constituents of psycho-social-spiritual healing: (I) how previous life experiences affected patients' present situations in dealing with their illnesses; (II) barriers to palliative care, and (III) benefits of palliative care. RESULTS: Of a total of 30 participants from 3 different study sites, 24 (80%) were receiving inpatient or outpatient palliative care at a research center. Thirteen (43%) participants were female, 10 (33%) were Black/African American, and 16 (53%) reported being on disability. While the initial shock of the diagnosis made participants feel unprepared for their illnesses, many looked to role models, previous work experiences, and spiritual as well as religious support as sources of strength and coping mechanisms. Barriers to palliative care were identified as either external (lack of proper resources) or internal (symptom barriers and perceived self-limitations). The feeling of "being seen/being heard" was perceived by many participants as the most beneficial aspect of palliative care. CONCLUSIONS: The needs assessment questionnaire and open-ended questions presented in this study may be used in clinical settings to better help patients achieve psycho-social-spiritual healing through palliative care and to help clinicians learn about the person behind the patient.

An assessment of meaning in life-threatening illness: development of the Healing Experience in All Life Stressors (HEALS).

CONTEXT: Patients with life-threatening or chronic illness report an experience of increased positive psychological, social, and/or spiritual change during diagnosis and/or treatment of their illness, even in the face of unfavorable prognosis. This transformation begins through the ability to make their life meaningful by forming meaningful connections that emerge through self-introspection and relationships with a divine entity, nature, and other people. The Healing Experience in All Life Stressors (HEALS) assessment provides a way to identify distress-causing changes that may interfere with the development of meaning and psycho-social-spiritual homeostasis. OBJECTIVE: Preliminary examination of responses to items on the HEALS and examination of the factor structure. METHOD: The 48-item HEALS questionnaire was developed using a multistep process: literature review for concept development, item generation from qualitative data, and face and content validity by expert panel. In the current study, HEALS was completed by 100 patients diagnosed with life-limiting disease and seen by the palliative care team at a large research institution in the US. Exploratory factor analysis techniques were used to determine scale structure of the instrument. RESULTS: Outcome testing of sample adequacy using Kaiser-Meyer-Olkin statistic was 0.75, which exceeds the recommended value of 0.60. The HEALS show very good internal consistency with a Cronbach's a of 0.94. Overall results of the exploratory factor analysis established a four-factor questionnaire: 1) religion; 2) spirituality, demonstrated by a) interaction with a religious community and b) belief in higher power; 3) intrapersonal; and 4) interpersonal relationships expressed through psychological changes resulting in enhanced outlook and improvement in relationships with family and friends. CONCLUSION: This study involved the initial step to commence the process of scale validation, with promising outcomes identifying subscales as an effective way to assess the construct of healing. These findings support further examination using cognitive appraisal and confirmatory factor analysis.

Symptom Clusters Change Over Time in Women Receiving Adjuvant Chemotherapy for Breast Cancer.

CONTEXT: Patients with breast cancer receiving chemotherapy (CTX) experience multiple concurrent symptoms, but little is known about how symptoms change during and after treatment. Knowledge of the identity and trajectory of symptom clusters (SCs) would enhance measurement and management. OBJECTIVES: We aimed to identify SCs and their change over time from baseline to completion of breast cancer CTX. METHODS: SCs were identified and assessed for change in 219 women from Nebraska at four times: baseline, during cycles #3 and #4 of CTX, and one month after finishing CTX. Ten symptoms were measured: two using the Hospital Anxiety and Depression Scale and eight using the Symptom Experience Scale. Exploratory factor analysis was conducted at each time point, then changes in SCs were evaluated at different times. RESULTS: Two SCs were identified before and after initiating CTX: gastrointestinal and treatment-related. The number and type of symptoms in each cluster differed over time. Clusters were dynamic during CTX with changes in the number and type of symptoms. Only one treatment-related SC, which consisted of fatigue, pain, and sleep disturbance, was identified after CTX completion. CONCLUSION: SCs during CTX appear to be dynamic, changing over time from before until after CTX completion. Repeated assessments of SCs reveal symptoms that are present and when patients are most burdened and in need of additional support.

Screening and assessment for obstructive sleep apnea in primary care.

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and contributes to increased morbidity and compromised cardiovascular outcomes. Sleep disorders are common but rarely reported and addressed by primary health providers. An American Academy of Sleep Medicine task force (2015) released quality measures for the care of adult patients with OSA; the first outcome is improved detection and categorization of OSA symptoms and severity to promote assessment and diagnosis of the disorder. This state of the science integrative review aimed to evaluate the screening and assessment for OSA in primary care settings including the psychometric properties of OSA screening measures. Studies that met inclusion criteria were fourteen non-experimental and three experimental designs. OSA screening measurements (Berlin questionnaire, Epworth sleepiness scale, STOP Bang) with extensive validation studies were examined. Conclusions are that the current practice model of screening and assessment for OSA in primary care is fragmented and ineffective. Primary care providers encounter patients with OSA symptoms but do not routinely screen, assess, or refer to a sleep specialist. More psychometric research is needed for the OSA screening measurements in primary care. The results of these studies can be translated into practice to increase detection of OSA.

An Evaluation of a Bereavement Program in a US Research Hospital.

The Bereavement Program at the National Institutes of Health (NIH) Clinical Center was established in 2005. The program makes contact with the next of kin on 4 occasions postnotification of death. The objective of this analysis was to evaluate program effectiveness for those individuals who we successfully made contact with on all 4 occasions (N = 39). At 12 months postnotification, the majority viewed the NIH as a source of support (56%), and the frequency of positive emotional ratings increased (59%). There are limitations to this analysis, and biases may be present. In sum, this analysis serves as an example of a successful hospital-based bereavement program that enrolls patients who have been treated at the institution in any capacity who are also patients enrolled in institutional review board-approved research protocols.

Increasing the Number of Outpatients Receiving Spiritual Assessment: A Pain and Palliative Care Service Quality Improvement Project.

BACKGROUND: Spirituality is a patient need that requires special attention from the Pain and Palliative Care Service team. This quality improvement project aimed to provide spiritual assessment for all new outpatients with serious life-altering illnesses. MEASURES: Percentage of new outpatients receiving spiritual assessment (Faith, Importance/Influence, Community, Address/Action in care, psychosocial evaluation, chaplain consults) at baseline and postinterventions. INTERVENTION: Interventions included encouraging clinicians to incorporate adequate spiritual assessment into patient care and implementing chaplain covisits for all initial outpatient visits. OUTCOMES: The quality improvement interventions increased spiritual assessment (baseline vs. postinterventions): chaplain covisits (25.5% vs. 50%), Faith, Importance/Influence, Community, Address/Action in care completion (49% vs. 72%), and psychosocial evaluation (89% vs. 94%). CONCLUSIONS/LESSONS LEARNED: Improved spiritual assessment in an outpatient palliative care clinic setting can occur with a multidisciplinary approach. This project also identifies data collection and documentation processes that can be targeted for improvement.

Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation.

PURPOSE: This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. METHODS: A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. RESULTS: It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. CONCLUSION: Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors.

Effective grant writing.

Infusion therapy nurses can be successful in obtaining research funding by understanding and executing the important steps of effective grant writing. This article provides information on and discussion about these essential steps to prepare successful applications: identifying funding options, recognizing the importance of writing time, implementing documentation on why research is needed, understanding the components of a research grant, implementing innovative ideas, and identifying characteristics of effectively written grants.

Cancer-related fatigue: the evidence base for assessment and management.

PURPOSE: Cancer-related fatigue contributes to negative outcomes relative to psychosocial and symptom distress, functional status, and quality of life, and yet it is often underdiagnosed and management is frequently suboptimal. DESIGN: Systematic database searches were conducted, and primary research reports and meta-analyses of quantitative studies of interventions for fatigue published in English were identified and critically examined. RESULTS: This paper reviews the etiology and evaluation of cancer-related fatigue and analyzes current empirical evidence supporting pharmacologic and nonpharmacologic techniques for its management. DISCUSSION: A variety of pharmacologic and nonpharmacologic techniques to manage cancer-related fatigue have been studied, although most of the evidence is from single-arm pilot studies with small sample sizes, rather than from adequately powered, multicenter, randomized controlled trials. Continued research in ethnically and racially diverse samples is needed to identify the interventions that are most effective in specific cancer subpopulations and to develop and test interventions for fatigue at each phase in the illness trajectory.