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1.
Support Care Cancer ; 32(6): 335, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38727834

ABSTRACT

PURPOSE: The Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Patient Antiemetic Guideline Committee aimed to (1) adapt the updated evidence-based, clinical guidelines to patient-centered antiemetic guidelines and (2) develop patient education materials and statements. METHODS: The MASCC 2023 Patient Antiemetic Guidelines were created and reviewed by antiemetic experts and patient advocates by incorporating the 2023 MASCC/ESMO antiemetic guidelines into patient-friendly language. Patient Education Statements were developed based on current literature and by utilizing an expert modified Delphi consensus (≥ 75% agreement). Patient advocate/focus group input and patient survey results were further integrated into Patient-Centered Antiemetic Guidelines and Education Statements. RESULTS: Patient-Centered Antiemetic Guidelines were created using patient-friendly language and visual slides. Patient-friendly language was also utilized to communicate the Educational Statements. Key content categories identified for the Educational Statements included the following: nausea/vomiting definitions, causes, risk factors, categories, complications, accompanying symptoms, prophylactic antiemetic treatment, general management, when to call/what to ask the healthcare team, what caregivers can do, and available resources. All identified content met the ≥ 75% expert agreement threshold. Fifteen (15) items demonstrated 100% agreement, 11 items achieved ≥ 90% agreement, and three content items demonstrated 80 ~ 82% agreement. CONCLUSIONS: The inaugural MASCC 2023 Patient Antiemetic Guidelines can help patients and caregivers understand the prevention of nausea and vomiting related to their cancer treatment. Educational Statements provide further patient information. Educating patients on how to utilize guideline antiemetics and the education statements can contribute improvements in the control of anticancer treatment-related nausea and vomiting.


Subject(s)
Antiemetics , Consensus , Evidence-Based Medicine , Nausea , Neoplasms , Patient Education as Topic , Patient-Centered Care , Vomiting , Humans , Antiemetics/therapeutic use , Antiemetics/administration & dosage , Vomiting/prevention & control , Nausea/prevention & control , Patient Education as Topic/methods , Patient Education as Topic/standards , Neoplasms/complications , Patient-Centered Care/methods , Delphi Technique , Practice Guidelines as Topic
2.
J Am Assoc Nurse Pract ; 36(3): 160-170, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-37962429

ABSTRACT

BACKGROUND: The widespread use of telehealth and regulatory changes that enhanced nurse practitioner (NP) practice authority because of the SARS-CoV-2 pandemic offers an opportunity to assess postpandemic NP satisfaction with telehealth care delivery and perceptions of its feasibility compared with in-person visits. PURPOSE: Outpatient chronic care delivery satisfaction and preference were compared among NPs who provide care to adults through in-person and/or telehealth visits and examined NP demographic and clinical characteristics associated with overall satisfaction by care delivery type. METHODOLOGY: Data were collected using a cross-sectional, descriptive design through online dissemination of The Care Delivery Satisfaction Survey to a nationally representative sample of 586 NPs. RESULTS: Compared with NPs using both visit types to deliver care, NPs delivering care in-person only had significantly lower satisfaction scores for interpersonal manner ( p = .0076) and communication ( p = .0108). NPs using telehealth only had significantly higher overall satisfaction and satisfaction subscale scores (all p < .01) compared with NPs using both visit types. Overall, 77% of NPs using both visit types preferred in-person delivery. CONCLUSIONS/IMPLICATIONS: NPs delivering telehealth care only were more satisfied with chronic care delivery than NPs using both delivery types. NPs using both types were more satisfied with interpersonal manner and communication compared with NPs delivering in-person care only. Most NPs using both types preferred in-person care delivery. Given increased telehealth use, health systems, academic institutions, and insurance companies can use these study findings to inform policy on telehealth resources and infrastructure.


Subject(s)
Nurse Practitioners , Telemedicine , Adult , Humans , Cross-Sectional Studies , Delivery of Health Care , Surveys and Questionnaires
3.
Support Care Cancer ; 32(1): 30, 2023 Dec 16.
Article in English | MEDLINE | ID: mdl-38102373

ABSTRACT

PURPOSE: Review the literature to propose suggestions or recommendations for controlling nausea and vomiting through integrative and non-pharmacological treatments for the MASCC/ESMO 2023 update of its antiemetic guidelines. METHODS: The authors identified available systematic reviews and/or meta-analyses for 12 integrative therapies, including acupressure, acupuncture, auricular therapy, electrical stimulation of point PC6, ginger use (i.e., Zingiber officinale), guided imagery, hypnosis, inhalation aromatherapy, music therapy, food-based interventions, progressive muscle relaxation, and reflexology. Reviews were assessed for quality through the AMSTAR2 tool. A consensus committee reviewed recommendations as per MASCC/ESMO established processes. RESULTS: Thirty-nine systematic reviews and/or meta-analyses were used. There were major methodological flaws for many of the trials used as the bases for the reviews. No recommendation for ingested ginger could be made because of conflicting evidence. Recommendations were possible for acupuncture/electroacupuncture treatments, food-based interventions, and progressive muscle relaxation training alone or combined with guided imagery. No recommendations could be reached for a number of food-based approaches, inhalation aromatherapy, hypnosis in adults, music therapy, and reflexology. CONCLUSION: While a limited number of suggestions are provided, there is a need for significantly higher quality trials in many of the therapeutic approaches assessed, before stronger recommendations and a wider range of approaches are made.


Subject(s)
Acupuncture Therapy , Antiemetics , Adult , Humans , Antiemetics/therapeutic use , Consensus , Nausea/therapy , Nausea/drug therapy , Vomiting/drug therapy , Practice Guidelines as Topic
4.
J Adv Pract Oncol ; 14(5): 414-418, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37576363

ABSTRACT

5-fluorouracil (5-FU) is one of the most common adjuvant antineoplastic agents used in the treatment of localized and metastatic colon cancer. Frequent side effects of 5-FU include myelosuppression, mucositis, nausea, vomiting, and diarrhea. However, hyperammonemic encephalopathy is a rare neurologic toxicity that can occur after 5-FU chemotherapy administration. Patients with 5-FU-induced hyperammonemic encephalopathy often exhibit symptoms of altered mental status with no radiologic abnormalities or laboratory abnormalities except for significantly elevated ammonia levels with occasional lactic acidosis and respiratory alkalosis. We report a case of a patient with stage IV colon adenocarcinoma who experienced altered state of consciousness due to hyperammonemia during the administration of palliative chemotherapy with 5-FU, bevacizumab, and leucovorin. On cycle 1 day 2 of chemotherapy, the patient became drowsy and confused at home, prompting a visit to the emergency department and ultimately hospital admission. Laboratory tests revealed an elevated blood ammonia level (838 µg/dL). After an extensive negative workup, his altered state of consciousness was thought to be secondary to 5-FU-induced hyperammonemia. Upon admission, 5-FU was immediately discontinued and the patient was treated with lactulose enemas, intravenous fluids, rifaximin, and continuous renal replacement therapy with gradual recovery to baseline mental status. It is crucial for advanced practitioners to be aware of this rare side effect to ensure prompt diagnosis and maximize treatment effectiveness.

5.
Gastroenterol Nurs ; 45(4): 238-243, 2022.
Article in English | MEDLINE | ID: mdl-35833740

ABSTRACT

This project is aimed to identify whether recovery times could be reduced in patients undergoing an outpatient liver biopsy. Liver biopsies are typically performed in a hospital setting, and many facilities require patients to recover for multiple hours, sometimes ranging from 4 to 6 hours. This can discourage the patient from undergoing the biopsy. Multiple studies have examined recovery times and determined patients can safely recover and be discharged within 1-2 hours post-liver biopsy. In this retrospective review, the data of 60 outpatients who underwent a liver biopsy from June to December 2020 were analyzed. Analysis included comparing vital signs and symptoms at the 2-hour recovery period and 4-hour discharge time also to see whether there were any hospital admissions 1 week post-liver biopsy. Descriptive statistics were utilized for the data collected in this study. Results demonstrated that after 2 hours, 55 (91.7%) patients had vital signs within safe parameters, pain less than 5 on a 10-point pain scale and denied any other symptoms. The remaining five patients (8.3%) did not meet discharge criteria at the 2-hour mark because of pain greater than 5 on the pain scale yet were still discharged safely at the 4-hour mark.


Subject(s)
Outpatients , Patient Discharge , Biopsy , Humans , Liver , Pain , Retrospective Studies
6.
Clin J Oncol Nurs ; 25(3): 314-320, 2021 Jun 01.
Article in English | MEDLINE | ID: mdl-34019034

ABSTRACT

BACKGROUND: Bone marrow procedures cause anxiety and pain in adult patients with cancer. Music is a safe, inexpensive, noninvasive intervention that is easy to implement and is well received by patients and providers. OBJECTIVES: The purpose of this quality improvement project was to develop, implement, evaluate, and sustain a music protocol during bone marrow biopsy and aspiration procedures for adult patients with hematologic malignancies. In addition, this project sought to decrease pain, anxiety, heart rate, and blood pressure in patients undergoing bone marrow procedures. METHODS: The project coordinator collected baseline data regarding toleration of bone marrow procedures and then implemented a music protocol during the procedures during a six-month intervention phase. Comparison variables included pain, anxiety, heart rate, blood pressure, and subjective impressions. FINDINGS: The music protocol resulted in improved patient anxiety, decreased procedure time, and decreased medication use during bone marrow procedures. All patients who used the music intervention indicated they would use it again.


Subject(s)
Music Therapy , Music , Adult , Anxiety/etiology , Anxiety/prevention & control , Bone Marrow , Humans , Pain/etiology , Pain/prevention & control , Pain Management
8.
J Adv Pract Oncol ; 11(7): 684-692, 2020.
Article in English | MEDLINE | ID: mdl-33575065

ABSTRACT

Patients with glioblastoma have poor overall survival and experience significant burden from neurologic decline and adverse treatment effects. Despite the well-known benefits of early palliative care integration with oncology care, utilization of palliative care is low. The purpose of this quality improvement (QI) project is to investigate the feasibility, value, and effectiveness of using an adapted palliative care screening tool to improve outpatient palliative care screening and referral of glioblastoma patients. This QI project was conducted over a 10-week period. A glioma palliative care screening tool was developed and integrated into outpatient visits. Providers were required to use the screening tool during each patient visit. Patients 18 years or older who were diagnosed with a World Health Organization grade IV glioma and returning to the neuro-oncology clinic for a brain MRI evaluation were targeted. Screening, palliative care discussion, and referral rates were evaluated. Among 530 eligible patients who returned to the clinic over a 10-week period, the tool was available for 433 patients. Fifty-six percent (n = 294/530) of the patients were screened. Nine percent (n = 27) of screened patients were identified as candidates for a palliative care referral (score ≥ 5 on the screening tool). Of these 27 patients, the proportion of patients who had a palliative care discussion was 63% (n = 17). Overall, 71% (n = 12) of patients who had a palliative care discussion were referred to a palliative care provider. Integrating a glioma palliative care screening tool with outpatient visits can draw attention to palliative care needs and lead to a referral to palliative care.

9.
Support Care Cancer ; 28(5): 2229-2238, 2020 May.
Article in English | MEDLINE | ID: mdl-31440823

ABSTRACT

PURPOSE: CINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, in spite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant has routinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen of aprepitant for glioma patients was investigated. METHODS: One hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150-200 mg/m2/day × 5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1-5 with aprepitant day 1: 125 mg, days 2-5: 80 mg) or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primary endpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤ 24 h) and delayed phase (days 2-7), as well as safety and quality of life (QoL). RESULTS: Patients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined as CC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p = 0.056). Treatment-related toxicities were mild or moderate in severity. CONCLUSIONS: Aprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV's effect on QoL, and is safe for 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate over ondansetron alone.


Subject(s)
Aprepitant/therapeutic use , Brain Neoplasms/drug therapy , Glioma/drug therapy , Nausea/prevention & control , Ondansetron/therapeutic use , Temozolomide/adverse effects , Vomiting/prevention & control , Adult , Aged , Antiemetics/therapeutic use , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Female , Humans , Male , Middle Aged , Nausea/chemically induced , Quality of Life , Temozolomide/therapeutic use , Vomiting/chemically induced
10.
J Hosp Palliat Nurs ; 21(4): 272-279, 2019 08.
Article in English | MEDLINE | ID: mdl-30893285

ABSTRACT

Nurses play an integral role in high-quality patient care. Thus, their skills in providing end-of-life care should be assessed and continually enhanced. Education intended to improve end-of-life skills must address the affective/emotional component of nursing care. Evidence demonstrates that emotional engagement and resilience among health care providers are correlated with improved quality outcomes and, conversely, that burnout and stress negatively affect patient safety. Addressing the emotional needs of health care providers is critical to improving quality throughout the health care system. An evidence-based workshop was implemented among direct care staff on a hospital-based palliative care unit, with the goal of fostering emotional engagement to improve staff perceptions and attitudes about caring for patients at or near the end of life. Although perceptions about quality of death were not affected by this intervention, there was a significant improvement in attitudes about end-of-life nursing care. Qualitative feedback also reflected appreciation for small group discussions and opportunities to debrief with peers away from the unit. This intervention reflected the value of emotional engagement in educational efforts to improve end-of-life nursing care.


Subject(s)
Hospice and Palliative Care Nursing/standards , Patients' Rooms/organization & administration , Perception , Attitude of Health Personnel , Hospice and Palliative Care Nursing/methods , Hospice and Palliative Care Nursing/statistics & numerical data , Humans , Outcome Assessment, Health Care , Patients' Rooms/statistics & numerical data
11.
Semin Oncol Nurs ; 34(5): 417-419, 2018 12.
Article in English | MEDLINE | ID: mdl-30446381
12.
Semin Oncol Nurs ; 34(5): 472-485, 2018 12.
Article in English | MEDLINE | ID: mdl-30409554

ABSTRACT

OBJECTIVES: To describe the adaptability to the patterns in symptoms and quality of life (QoL) during 6 months post low-grade glioma diagnosis by valid and reliable tools; to identify through qualitative interviews patient/provider adaptive techniques and strategies; and to assess associations among patient characteristics, symptoms and QoL, and adaptive techniques or strategies. DATA SOURCES: Demographic, clinical and pathologic data from medical records. Validated instruments that assess QoL, fatigue, depression, and distress were completed at 2, 4, and 6 months post diagnosis. Qualitative interviews identifying the symptoms, challenges, adaptive techniques and strategies were conducted at 4 and 6 months. CONCLUSION: The most frequently used adaptive strategies included: obtaining community support (87%), managing expectations (73%) and support systems (67%), and seeking out knowledge about physical (67%) and behavioral symptoms (53%). Seizures were reported with IDH1mut (11%) but not IDH1wildtype. Patients with either IDH1mut or TERTmut consistently reported lower QoL and higher distress, depression, and fatigue scores. IDH1/TERTmut may be related to lower QoL because of IDH1mut-related seizures. IMPLICATIONS FOR NURSING PRACTICE: Findings provide a list of adaptive strategies and characteristics to address the problems and symptoms that may improve overall QoL in patients with low-grade glioma.


Subject(s)
Adaptation, Psychological , Brain Neoplasms/psychology , Glioma/psychology , Quality of Life/psychology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Pilot Projects
13.
Oncologist ; 23(8): 889-e98, 2018 08.
Article in English | MEDLINE | ID: mdl-29666296

ABSTRACT

LESSONS LEARNED: Due to evolving imaging criteria in brain tumors and variation in magnetic resonance imaging evaluation, it is not ideal to use response rate as a primary objective. Future studies involving antiangiogenic agents should use overall survival.Disease-expected toxicities should be considered when defining the clinical significance of an adverse event. For example, vascular thromboembolic events are common in brain tumor patients and should not be attributed to the study drug in the safety analysis. BACKGROUND: Recurrent malignant glioma (rMG) prognosis is poor, with a median patient survival of 3-11 months with bevacizumab (BEV)-containing regimens. BEV in rMG has 6-month progression free survival (PFS-6) of ∼40% and an objective response rate of 21.2%. BEV-containing regimens improve PFS-6 to 42.6%-50.3%, indicating that BEV combination therapies may be superior to single agent. Rilotumumab, a hepatocyte growth factor (HGF) antibody, inhibits angiogenesis and expression of angiogenic autocrine factors (e.g., vascular endothelial growth factor [VEGF]) by c-Met inhibition. Combination of rilotumumab with BEV to block vascular invasion and tumor proliferation may synergistically inhibit tumor growth. METHODS: Thirty-six BEV-naïve rMG subjects received rilotumumab (20 mg/kg and BEV (10 mg/kg) every 2 weeks. Endpoints included objective response rate (using Response Assessment in Neuro-Oncology [RANO] criteria), PFS-6, overall survival (OS), and toxicity. RESULTS: Median patient follow-up was 65.0 months. Objective response rate was 27.8% (95% confidence interval [CI]: 15.7%-44.1%). Median OS was 11.2 months (95% CI: 7-17.5). PFS-6 was 41.7% (95% CI: 25.6%-57.0%). Most frequent treatment-related grade ≤2 events included weight gain, fatigue, allergic rhinitis, and voice alteration; grade ≥3 events included venous thromboembolism (four patients), including one death from pulmonary embolism. CONCLUSION: Rilotumumab with BEV did not significantly improve objective response compared with BEV alone, and toxicity may preclude the use of rilotumumab in combination BEV regimens.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Bevacizumab/therapeutic use , Glioma/drug therapy , Adult , Aged , Antibodies, Monoclonal/pharmacology , Antibodies, Monoclonal, Humanized , Bevacizumab/pharmacology , Female , Glioma/pathology , Humans , Male , Middle Aged
14.
Support Care Cancer ; 26(2): 557-564, 2018 02.
Article in English | MEDLINE | ID: mdl-28871358

ABSTRACT

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) can be prevented in most patients with use of guideline-recommended antiemetic regimens. However, studies have suggested that adherence to antiemetic guidelines is suboptimal. Oncology nurses, as part of a multidisciplinary team, can help promote appropriate antiemetic prophylaxis. Therefore, nurses were surveyed to assess antiemetic guideline awareness and practice patterns of antiemetic use, determine adherence to guideline recommendations, and query barriers to adherence. METHODS: In September 2015, 531 US-based oncology nurses participated in an online survey administered and analyzed by ONS:Edge. RESULTS: Nurses were most familiar with National Comprehensive Cancer Network (73%) and American Society of Clinical Oncology (48%) antiemetic guidelines. While most (77%) felt that antiemetics prescribed were consistent with guideline recommendations, practice patterns of antiemetic use revealed low adherence to those guidelines, particularly during the delayed (25-120 h) phase following highly emetogenic chemotherapy, where only 25% of nurses reported administration of guideline-recommended agents. Overutilization of phenothiazines and benzodiazepines was common. Only 17% of respondents reported that most (> 75%) of their patients have CINV optimally controlled; 39% reported between 6 and 20% of patients have an alteration in their chemotherapy due to CINV, and reports of emergency department/hospital visits due to poorly controlled CINV were high. The predominant barrier interfering guideline-recommended antiemetic prophylaxis was reported as physician preference (71%). CONCLUSIONS: This survey revealed an opportunity to increase awareness of antiemetic guidelines and a critical need to address barriers interfering with utilization of guideline-recommended antiemetic agents in order to optimize CINV control for patients undergoing emetogenic chemotherapy.


Subject(s)
Antiemetics/therapeutic use , Induction Chemotherapy/adverse effects , Medication Adherence/psychology , Nausea/chemically induced , Vomiting/chemically induced , Antiemetics/pharmacology , Female , Humans , Male , Nurse Clinicians , Surveys and Questionnaires
15.
J Adv Pract Oncol ; 9(5): 475-486, 2018.
Article in English | MEDLINE | ID: mdl-31086684

ABSTRACT

In medicine, neuro-oncology practice falls outside the scope of established practice requirements for the specialties of neurology, medical oncology, and neurosurgery, justifying the prerequisite of specialized training to practice neuro-oncology. Neuro-oncology advanced practitioners (AP) also require specialization beyond the scope of population-based generalist training and education. This quality improvement project's primary purpose was to develop a professional practice model (PPM) for APs employed at an academic medical center (AMC) ambulatory neuro-oncology practice. Using the focus, analyze, develop, execute, and evaluate (FADE) quality improvement methodology, the authors (1) reviewed literature and relevant professional organizations to identify possible professional competencies for neuro-oncology APs; (2) analyzed data to develop evidence-based practice domains; (3) used purposive sampling to recruit an interprofessional team of neuro-oncology experts; and (4) conducted a Delphi study with an interprofessional team of experts to gain consensus on practice domains and professional competencies. Twenty-three participants (n = 23) were recruited for the Delphi study, which was executed via electronic transmission using the Web-based software Qualtrics. After two rounds of the Delphi survey, the expert team reached consensus on six domains of practice, with 50 corresponding competency statements. Through interprofessional collaboration and consensus, this quality improvement project successfully created a PPM for an AMC neuro-oncology AP team. The PPM supports neuro-oncology APs by validating the unique set of skills that combines several specialties. The PPM provided the framework to standardize orientation and training, evaluate performance, and support the professional development of an AMC neuro-oncology AP team.

16.
J Neurooncol ; 134(2): 363-369, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28669010

ABSTRACT

Primary brain tumor patients experience high levels of distress. The purpose of this cross-sectional, retrospective study is to evaluate the level and different sources of psychosocial distress and how these pertain to health-related quality of life (HRQoL). The Primary and Recurrent Glioma registry at Duke's The Preston Robert Tisch Brain Tumor Center was queried retrospectively for demographic and clinical information on patients seen between December 2013 and February 2014. Data also included the National Comprehensive Cancer Network's Distress Thermometer (NCCN-DT), Functional Assessment of Cancer Therapy-Brain Cancer (FACT-Br), and Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F). 829 subjects completed questionnaires. 54% were male; 96% completed the NCCN-DT; 33.3% had a DT score ≥4 (moderate/severe distress). Women reported DT ≥ 4 more often than men (38.6 vs 29.0%; p = 0.005). Patients within 1 year of diagnosis reported DT ≥ 4 more often than those 1+ years after diagnosis (38.8 vs 30.9%; p = 0.034). 73.0% reported physical problems; the most frequent being fatigue (43.2%) and memory/concentration (40.9%). 42.0% complained of emotional problems with worry (29.4%) and nervousness (22.4%) being the most common. Patients who reported at least one practical, family, emotional or physical problem had significantly lower HRQoL scores (p < 0.001). Primary brain tumor patients experience memory dysfunction, fatigue, nervousness, worry, and financial concerns, which have a negative effect on the patient's HRQoL. By identifying and addressing these stressors, it may be possible to improve patient HRQoL.


Subject(s)
Brain Neoplasms/psychology , Quality of Life , Stress, Psychological , Adolescent , Adult , Aged , Aged, 80 and over , Brain Neoplasms/complications , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Registries , Retrospective Studies , Sex Factors , Stress, Psychological/epidemiology , Surveys and Questionnaires , Time Factors , Young Adult
17.
Ther Clin Risk Manag ; 13: 33-40, 2017.
Article in English | MEDLINE | ID: mdl-28096679

ABSTRACT

PURPOSE: Given that the prognosis of recurrent malignant glioma (MG) remains poor, improving quality of life (QoL) through symptom management is important. Meta-analyses establishing antiemetic guidelines have demonstrated the superiority of palonosetron (PAL) over older 5-hydroxytryptamine 3-receptor antagonists in chemotherapy-induced nausea and vomiting (CINV) prevention, but excluded patients with gliomas. Irinotecan plus bevacizumab is a treatment frequently used in MG, but is associated with low (55%) CINV complete response (CR; no emesis or use of rescue antiemetic) with commonly prescribed ondansetron. A single-arm Phase II trial was conducted in MG patients to determine the efficacy of intravenous PAL (0.25 mg) and dexamethasone (DEX; 10 mg) received in conjunction with biweekly irinotecan-bevacizumab treatment. The primary end point was the proportion of subjects achieving acute CINV CR (no emesis or antiemetic ≤24 hours postchemotherapy). Secondary end points included delayed CINV CR (days 2-5), overall CINV CR (days 1-5), and QoL, fatigue, and toxicity. MATERIALS AND METHODS: A two-stage design of 160 patients was planned to differentiate between CINV CR of 55% and 65% after each dose of PAL-DEX. Validated surveys assessed fatigue and QoL. RESULTS: A total of 63 patients were enrolled, after which enrollment was terminated due to slow accrual; 52 patients were evaluable for the primary outcome of acute CINV CR. Following PAL-DEX dose administrations 1-3, acute CINV CR rates were 62%, 68%, and 70%; delayed CINV CR rates were 62%, 66%, and 70%, and overall CINV CR rates were 47%, 57%, and 62%, respectively. Compared to baseline, there was a clinically meaningful increase in fatigue during acute and overall phases, but not in the delayed phase. There were no grade ≥3 PAL-DEX treatment-related toxicities. CONCLUSION: Data suggest that PAL-DEX is effective in preventing CINV in MG patients, which ultimately maintains the QoL of patients with glioma.

18.
Support Care Cancer ; 24(10): 4365-75, 2016 10.
Article in English | MEDLINE | ID: mdl-27271867

ABSTRACT

BACKGROUND: In malignant glioma (MG) patients undergoing radiation therapy (RT) with concomitant temozolomide, chemoradiation-induced nausea and vomiting (cRINV) degrades quality of life (QoL) and reduces treatment adherence, which thereby potentially compromises cancer control. METHODS: We conducted a 6-week phase II single-arm trial of PAL, a second-generation 5-HT3RA antiemetic, for cRINV prevention in MG patients receiving radiation therapy (RT; 54-60 Gy) and concomitant daily temozolomide (TMZ; 75 mg/m(2)/dX42d). Each week before radiation, patients received single-dose palonosetron (PAL) 0.25 mg IV (total = 6 doses). With safety/tolerability as the primary endpoint, the study was designed to differentiate between toxicity rates of 25 % (unacceptable) and 10 % (acceptable) toxicity rates. Secondary endpoints included the percentage of patients achieving cRINV complete response (CR: no emesis or rescue antiemetic) and QoL. Patients reported adverse effects in Common Toxicity Criteria for Adverse Events diaries; recorded vomiting, nausea, and rescue medication use in diaries (which were used to assess cRINV-CR); and reported QoL 4 days/week using the Modified Functional Living Index-Emesis (M-FLIE) and Osoba nausea and vomiting/retching modules. RESULTS: We enrolled 38 patients (mean age 59 years, 55 % female, 95 % white, 68 % used oral corticosteroids, 76 % reported low alcohol use). Four patients (10.5 %) experienced unacceptable treatment-related toxicity, defined as any grade 3, 4, or 5 non-hematologic toxicity. M-FLIE and Osoba scores showed no evidence of treatment impact on QoL. Overall, cRINV-CR rates for 6 weeks ranged from 67-79 %. CONCLUSION: Single-dose weekly PAL is a safe and tolerable antiemetic for cRINV prevention in MG patients receiving standard RT and concomitant TMZ.


Subject(s)
Antineoplastic Agents/therapeutic use , Chemoradiotherapy/methods , Dacarbazine/analogs & derivatives , Glioma/drug therapy , Glioma/radiotherapy , Isoquinolines/therapeutic use , Quality of Life/psychology , Quinuclidines/therapeutic use , Administration, Intravenous , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/pharmacology , Dacarbazine/adverse effects , Dacarbazine/pharmacology , Dacarbazine/therapeutic use , Female , Glioma/pathology , Humans , Isoquinolines/adverse effects , Isoquinolines/pharmacology , Male , Middle Aged , Palonosetron , Quinuclidines/adverse effects , Quinuclidines/pharmacology , Surveys and Questionnaires , Temozolomide
19.
Cancer Manag Res ; 6: 329-37, 2014.
Article in English | MEDLINE | ID: mdl-25228819

ABSTRACT

Prevention of chemotherapy-induced nausea and vomiting (CINV) is a key component of treatment for patients with cancer. Guidelines are available to assist prescribers in the management of CINV associated with single-day chemotherapy regimens. However, currently there are no clear guidelines for management of CINV in patients receiving multiple-day chemotherapy regimens. Serotonin (5-HT3) receptor antagonists are a mainstay in preventing CINV, and palonosetron, given its longer half-life and duration of action relative to other 5-HT3 receptor antagonists, may be a useful option for managing CINV in multiple-day chemotherapy. Here we provide an overview of CINV and CINV treatment options, with a focus on palonosetron. We describe existing challenges in managing CINV, and discuss two patients receiving multiple-day chemotherapy, in whom CINV was managed successfully with palonosetron.

20.
Support Care Cancer ; 22(7): 1897-905, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24570103

ABSTRACT

PURPOSE: A quality improvement project was implemented to improve adherence to evidence-based antiemetic guidelines for malignant glioma patients treated with moderately emetic chemotherapy (MEC). Poorly controlled chemotherapy-induced nausea and vomiting (CINV) reduce cancer treatment efficacy and significantly impair cancer patients' quality of life (QOL). A review of Duke University Preston Robert Tisch Brain Tumor Center (PRTBTC)'s usual practice demonstrates a high incidence (45%) of CINV, despite premedication with short-acting 5-HT3-serotonin-receptor antagonists (5-HT3-RAs). National Comprehensive Cancer Network (NCCN)'s evidence-based guidelines recommend the combination of the long-acting 5-HT3-RA palonosetron (PAL) and dexamethasone (DEX) for the prevention of acute and delayed CINV with MEC. Low adherence (58%) to antiemetic guidelines may have explained our high CINV incidence. METHODS: One-sample binomial test, quasi-experimental design, evaluated a combination intervention that included a provider education session; implementation of risk-assessment tool with computerized, standardized antiemetic guideline order sets; and a monthly audit-feedback strategy. Post-implementation adherence to evidence-based antiemetic order sets and patient outcomes were measured and compared to baseline and historical data. Primary outcome was the guideline order set adherence rate. Secondary outcomes included nausea/vomiting rates and QOL. RESULTS: Adherence to ordering MEC guideline antiemetics increased significantly, from 58% to a sustained 90%, with associated improvement in nausea/vomiting. In acute and delayed phases, 75 and 84% of patients, respectively, did not experience CINV. There was no significant change in QOL. CONCLUSION: Combination intervention and audit-feedback strategy to translate evidence into oncology practice improved and sustained adherence to antiemetic guidelines. Adherence corresponded with effective nausea/vomiting control and preserved QOL in patients with malignant gliomas.


Subject(s)
Antiemetics/administration & dosage , Brain Neoplasms/drug therapy , Glioblastoma/drug therapy , Medication Adherence , Nausea/prevention & control , Vomiting/prevention & control , Adult , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Dexamethasone/administration & dosage , Female , Humans , Isoquinolines/administration & dosage , Male , Middle Aged , Nausea/chemically induced , Nausea/drug therapy , Neoplasms/drug therapy , Palonosetron , Quality of Life , Quinuclidines/administration & dosage , Serotonin 5-HT3 Receptor Antagonists/administration & dosage , Translational Research, Biomedical , Treatment Outcome , Vomiting/chemically induced , Vomiting/drug therapy
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