RESUMEN
Nutrition is essential for peripheral nerve function, yet dietary factors associated with chronic chemotherapy-induced peripheral neuropathy (CIPN) remain poorly characterized. The purpose of this cross-sectional study was to determine differences in diet quality and macronutrients for cancer survivors with and without CIPN. Cancer survivors (e.g., ≥3 months post platinum and/or taxane-based neurotoxic chemotherapy) with (i.e., ≥1/4 PRO-CTACE™ Numbness and Tingling Severity) and without CIPN completed the VioScreen Research Graphical Food Frequency Questionnaire. The association among diet (Healthy Eating Index [HEI]), macronutrient intake (average percent caloric intake), and CIPN severity were analyzed using generalized linear regression models, adjusting for caloric intake, body mass index, age, and sex. Results revealed that for each one-point increase in diet quality, PRO-CTCAE severity decreased by -0.06 (95% CI: -0.10, -0.02, P < 0.01). Participants without CIPN reported higher diet quality than those with CIPN (HEI mean: 70.11 vs 68.45) (OR = 0.94, P = 0.03, 95% CI: 0.89, 0.99). Participants with CIPN had significantly higher carbohydrate consumption than participants without CIPN (OR = 1.11, P = 0.04, 95% CI: 1.01, 1.22). There were no significant differences in consumption of proteins or fats between groups. Further research should be pursued to discover the potential benefits of dietary interventions for CIPN management among cancers survivors.
Asunto(s)
Antineoplásicos , Supervivientes de Cáncer , Dieta , Enfermedades del Sistema Nervioso Periférico , Humanos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Supervivientes de Cáncer/estadística & datos numéricos , Femenino , Masculino , Persona de Mediana Edad , Estudios Transversales , Antineoplásicos/efectos adversos , Anciano , Adulto , Dieta Saludable/estadística & datos numéricos , Neoplasias/tratamiento farmacológico , Neoplasias/complicaciones , Ingestión de EnergíaRESUMEN
PURPOSE: This white paper provides guidance regarding the process for establishing and maintaining international collaborations to conduct oncology/neurology-focused chemotherapy-induced peripheral neurotoxicity (CIPN) research. METHODS: An international multidisciplinary group of CIPN scientists, clinicians, research administrators, and legal experts have pooled their collective knowledge regarding recommendations for establishing and maintaining international collaboration to foster advancement of CIPN science. RESULTS: Experts provide recommendations in 10 categories: (1) preclinical and (2) clinical research collaboration; (3) collaborators and consortiums; (4) communication; (5) funding; (6) international regulatory standards; (7) staff training; (8) data management, quality control, and data sharing; (9) dissemination across disciplines and countries; and (10) additional recommendations about feasibility, policy, and mentorship. CONCLUSION: Recommendations to establish and maintain international CIPN research collaboration will promote the inclusion of more diverse research participants, increasing consideration of cultural and genetic factors that are essential to inform innovative precision medicine interventions and propel scientific discovery to benefit cancer survivors worldwide. RELEVANCE TO INFORM RESEARCH POLICY: Our suggested guidelines for establishing and maintaining international collaborations to conduct oncology/neurology-focused chemotherapy-induced peripheral neurotoxicity (CIPN) research set forth a challenge to multinational science, clinical, and policy leaders to (1) develop simple, streamlined research designs; (2) address logistical barriers; (3) simplify and standardize regulatory requirements across countries; (4) increase funding to support international collaboration; and (5) foster faculty mentorship.
Asunto(s)
Antineoplásicos , Supervivientes de Cáncer , Síndromes de Neurotoxicidad , Enfermedades del Sistema Nervioso Periférico , Humanos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Antineoplásicos/efectos adversos , Síndromes de Neurotoxicidad/etiología , Síndromes de Neurotoxicidad/tratamiento farmacológico , Personal AdministrativoRESUMEN
OBJECTIVE: The purpose of this secondary analysis was to describe the prevalence of anxiety, depression, and perceived stress among women newly diagnosed with breast cancer and the impact of baseline and changes in anxiety on cognitive functioning following exercise and mind-body prehabilitation interventions. METHODS: The sample consisted of 49 women with newly diagnosed breast cancer (stages I-III) who planned to undergo breast cancer surgery at two academic cancer centers. Participants were randomized to receive an exercise or mind-body prehabilitation intervention between the time of diagnosis and breast cancer surgery. Participants completed self-report measures of anxiety, depression (HADS), perceived stress, and cognitive functioning (EORTC-QLQ-C30) at study enrollment and prior to surgery (post-intervention). The relationships between change in cognitive functioning and change in anxiety among all participants were estimated using linear regression modeling. RESULTS: A significant proportion of women with newly diagnosed breast cancer had clinically significant anxiety (34.0%). Greater anxiety was moderately associated with worse cognitive functioning (r = -0.33) at baseline. Linear modeling found that changes in cognitive functioning and anxiety were inversely related: Each one-unit decrease in anxiety was associated with a two-unit improvement in cognitive function (p = .06). CONCLUSIONS: Anxiety was common in women with newly diagnosed breast cancer and was related to worse cognitive functioning. Assessment of anxiety at the time of diagnosis may allow for earlier anxiety management and subsequent improvement in cognitive functioning.
RESUMEN
Little quantitative evidence exists surrounding patients' level of understanding of chemotherapy-induced peripheral neuropathy (CIPN) symptoms (numbness, tingling, pain in the hands/feet) and consequences (e.g., negatively affect physical functioning or chemotherapy dosing) at the beginning of chemotherapy. The purpose of this cross-sectional, secondary analysis was to describe CIPN knowledge and education patterns among adults early in a course of neurotoxic chemotherapy for the treatment of cancer (< three infusions). Following consent, participants completed an electronic questionnaire about their perceptions of CIPN symptoms, incidence, and education. Participants (N = 92) were mainly female (76%), white (91%), and diagnosed with breast (46%) or gastrointestinal (40%) cancers. Most participants without CIPN (n = 48) did not expect to develop CIPN (45%) or were unaware of CIPN as a side-effect (30%). Furthermore, 71% of participants without CIPN (n = 31) estimated CIPN to occur in ≤ 30% of patients receiving neurotoxic chemotherapy. Overall, participants learned about CIPN from their doctor or nurse prior to beginning chemotherapy (90%). Clinicians delivered education about CIPN symptoms (75%), but less frequently delivered education about CIPN management (14%), or the impact of CIPN on the ability to continue chemotherapy (16%) or physical functioning (24%). Finally, participants reported that a discussion with their doctor/nurse would be the best way to learn about CIPN (92%). Results revealed that participants without CIPN were largely unaware of the adverse consequences or incidence of CIPN during treatment. Further research is needed to investigate optimal methods to promote patient-clinician communication about CIPN during chemotherapy to enhance patients' retention of CIPN information and activation in their care.
Asunto(s)
Antineoplásicos , Neoplasias , Enfermedades del Sistema Nervioso Periférico , Adulto , Humanos , Femenino , Masculino , Estudios Transversales , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapia , Neoplasias/tratamiento farmacológico , Dolor , Antineoplásicos/efectos adversos , Calidad de VidaRESUMEN
PURPOSE: There are no recommended treatments for chemotherapy-induced peripheral neuropathy (CIPN) prevention. Recruitment to CIPN prevention clinical trials is challenging because it is difficult to enroll patients between the time of cancer diagnosis and the initiation of neurotoxic chemotherapy. The purpose of this exploratory-sequential mixed-methods study was to determine patients' preferences that could affect the choice to participate in CIPN prevention clinical trials. METHODS: First, twenty cognitive interviews were conducted with adults who completed less than three neurotoxic chemotherapy infusions to clarify clinical trial attributes and levels thought to be important to patients when deciding whether to enroll in CIPN prevention trials (i.e., type of treatment, clinical tests, reimbursement, survey delivery; length of visits, timing of follow-up, when to begin treatment). Second, another eighty-eight patients completed an adaptive choice-based conjoint analysis survey that incorporated the finalized attributes and levels. Each level was assigned a part-worth utility score using Hierarchical Bayes Estimation. The relative importance of each attribute was calculated. RESULTS: The attributes with the highest relative importance values were type of treatment (27.1%) and length of study visits (20.2%). The preferred levels included non-medicine treatment (53.49%), beginning treatment after experiencing CIPN (60.47%), email surveys (63.95%), assessments that include surveys and clinical exams (39.53%), under 30-min visits (44.19%), $50/week reimbursement (39.53%), and 1-month post-chemotherapy follow-up visits (32.56%). CONCLUSIONS: Patients' preferences for participation may be included in the design of future CIPN prevention clinical trials to potentially bolster study enrollment.
Asunto(s)
Antineoplásicos , Enfermedades del Sistema Nervioso Periférico , Adulto , Humanos , Antineoplásicos/efectos adversos , Teorema de Bayes , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/prevención & control , Encuestas y Cuestionarios , Prioridad del PacienteRESUMEN
PURPOSE: To compare the impact of exercise and mind-body prehabilitation interventions on changes in quality of life and cancer treatment-related symptoms in women with newly diagnosed breast cancer. METHODS: The following describes a secondary analysis of a randomized window of opportunity trial (The Pre-Operative Health and Body Study). Forty-nine women were randomized to participate in either an exercise prehabilitation intervention or a mind-body prehabilitation intervention from the time of enrollment to surgery. Participants (N = 47) completed measures of quality of life, anxiety, depression, and stress at the time of enrollment (T1), post-intervention/surgery (T2), and one-month post-surgery (T3). Changes in outcome measures between groups were compared over time using longitudinal models. RESULTS: Mind-body group participants experienced significant improvements in cognitive functioning in comparison to exercise group participants between T1 and T3 (difference in average change: -9.61, p = 0.04, d = 0.31), otherwise, there were no significant differences between groups. Within group comparisons demonstrated that both groups experienced improvements in anxiety (exercise: average change = -1.18, p = 0.03, d = 0.34; mind-body: average change = -1.69, p = 0.006, d = 0.43) and stress (exercise: average change = -2.33, p = 0.04, d = 0.30; mind-body: average change = -2.59, p = 0.05, d = 0.29), while mind-body group participants experienced improvements in insomnia (average change = -10.03, p = 0.04, d = 0.30) and cognitive functioning (average change = 13.16, p = 0.0003, d = 0.67). CONCLUSIONS: Both prehabilitation interventions impacted cancer treatment-related symptoms. Further work in larger groups of patients is needed to evaluate the efficacy of prehabilitation interventions on quality of life in women with breast cancer. Pre-operative exercise and mind-body interventions may impact physical and/or psychological effects of cancer diagnosis and treatment in women with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01516190. Registered January 24, 2012.
Asunto(s)
Neoplasias de la Mama , Ejercicio Preoperatorio , Neoplasias de la Mama/cirugía , Ejercicio Físico , Femenino , Humanos , Terapias Mente-Cuerpo , Calidad de VidaRESUMEN
BACKGROUND: The early identification of chemotherapy-induced peripheral neuropathy (CIPN) (e.g., numbness or tingling in the fingers or toes) is important due to its frequency and the few effective treatment options available. The identification of common patient-reported CIPN characteristics and associated functional limitations may help to facilitate patient-clinician discussions of CIPN in practice. AIMS: To quantify the severity, duration, location, characteristics, and associated functional limitations of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. DESIGN: Exploratory secondary analysis of a prospective, two-phase study SETTING: Breast, gastrointestinal, and multiple myeloma clinics at Dana-Farber Cancer Institute. PARTICIPANTS: 142 individuals who planned to receive at least three more cycles of neurotoxic chemotherapy after consent. METHODS: Participants self-reported CIPN using standardized measures (i.e., PRO-CTCAE™ Numbness and Tingling Items or 0-10 numerical rating scale of worst CIPN pain intensity) and/or study team generated follow up questions about CIPN location, duration, characteristics, and functional limitations prior to three consecutive clinic visits (T1, T2, T3). Participants' responses to the CIPN self-report questionnaires were described by chemotherapy type and age. RESULTS: Over approximately 36.5 days (T1-T3), the percentage of participants reporting at least mild CIPN increased from 59.3% to 71%. At T3, patients with non-painful (n = 98) or painful neuropathy (n = 34) frequently reported symptoms in the fingers (non-painful = 83.5%, painful = 76.5%) or toes (non-painful = 49.5%, painful = 41.2%) and characterized symptoms as numbness (non-painful = 54.1%, painful = 50%) or tingling (non-painful = 68.4%, painful = 82.4%). Self-reported CIPN functional limitations (n = 55) included difficulties with buttoning a shirt (38.2%) or walking (25.5%). Paclitaxel-related CIPN (n = 33) was frequently characterized as "continuous" (30.3%), whereas oxaliplatin-related CIPN (n = 51) was frequently characterized as "intermittent" (41.2%). Young adults (15-39 years old, n = 15) frequently reported moderate-severe non-painful CIPN (46.7%), painful CIPN (40%), and CIPN interference (33.3%). CONCLUSIONS: Consistent with qualitative research, participants frequently described CIPN as numbness and/or tingling in the fingers and/or toes.
Asunto(s)
Antineoplásicos , Enfermedades del Sistema Nervioso Periférico , Adolescente , Adulto , Antineoplásicos/efectos adversos , Humanos , Hipoestesia/inducido químicamente , Hipoestesia/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Estudios Prospectivos , Autoinforme , Adulto JovenRESUMEN
With the rise in telehealth due to the COVID-19 pandemic, further research is needed to determine how to optimize virtual delivery of existing integrative oncology interventions for cancer treatment-related symptoms. The purpose of this qualitative analysis was to explore cancer survivors' perspectives of the acceptability and satisfaction of an 8-week, virtual yoga intervention for cancer survivors with chronic chemotherapy-induced peripheral neuropathy pain. Fourteen participants with chronic chemotherapy-induced peripheral neuropathy pain who completed the virtual yoga intervention were interviewed using a semistructured interview guide. Themes were derived from the data using inductive content analysis methods. Main findings from the interviews included the following: (1) participants were willing to try new nonpharmacological treatments for chemotherapy-induced peripheral neuropathy due to the high symptom burden and prior lack of success with medications; (2) participants highly rated the flexibility offered by the virtual format, but desired the social support potentially offered by practicing in-person yoga; and (3) the impact of virtual yoga on chemotherapy-induced peripheral neuropathy severity was unclear. There were several barriers to participants' use of virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain (eg, technology, lack of space/equipment). The results may be used to improve the design and delivery of future trials testing virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain.
Asunto(s)
Antineoplásicos , COVID-19 , Supervivientes de Cáncer , Dolor Crónico , Neoplasias , Enfermedades del Sistema Nervioso Periférico , Yoga , Antineoplásicos/efectos adversos , Dolor Crónico/tratamiento farmacológico , Humanos , Pandemias , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapiaRESUMEN
BACKGROUND: The US opioid epidemic has prompted dramatic changes in public attitudes and regulations governing opioid prescribing. Little is known about the experiences of patients with advanced cancer using opioids in the context of the epidemic. METHODS: Semistructured interviews of 26 patients with advanced cancer were conducted between May 2019 and April 2020; their experiences self-managing chronic pain with opioids were evaluated. RESULTS: Patients consistently described the negative impact of the opioid epidemic on their ability to self-manage pain. Negative media coverage and personal experiences with the epidemic promoted stigma, fear, and guilt surrounding opioid use. As a result, many patients delayed initiating opioids and often viewed their decision to take opioids as a moral failure-as "caving in." Patients frequently managed this internal conflict through opioid-restricting behaviors (eg, skipping or taking lower doses). Stigma also impeded patient-clinician communication; patients often avoided discussing opioids or purposely conveyed underusing them to avoid being labeled a "pill seeker." Patients experienced structural barriers to obtaining opioids such as prior authorizations, delays in refills, or being questioned by pharmacists about their opioid use. Barriers were stressful, amplified stigma, interfered with pain control, and reinforced ambivalence about opioids. CONCLUSIONS: The US opioid epidemic has stigmatized opioid use and undermined pain management in individuals with advanced cancer. Interventions seeking to alleviate cancer pain should attend to the multiple, negative influences of the opioid crisis on patients' ability to self-manage. LAY SUMMARY: Patients with advanced cancer suffer from significant pain and frequently receive opioids to manage their pain. Of the 26 patients with advanced cancer interviewed, the majority of patients experienced stigma about their opioid use for cancer pain management. All patients felt that the opioid epidemic fostered this stigma. Several struggled to use opioids for pain because of this stigma and the logistical complications they experienced with pharmacies and insurance coverage. Many were afraid to share their concerns about opioids with their providers. â.
Asunto(s)
Dolor en Cáncer , Dolor Crónico , Neoplasias , Automanejo , Analgésicos Opioides/efectos adversos , Dolor en Cáncer/tratamiento farmacológico , Dolor en Cáncer/epidemiología , Humanos , Neoplasias/inducido químicamente , Neoplasias/complicaciones , Neoplasias/epidemiología , Epidemia de Opioides , Manejo del Dolor , Pautas de la Práctica en MedicinaRESUMEN
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) negatively affects physical function and chemotherapy dosing, yet, clinicians infrequently document CIPN assessment and/or adhere to evidence-based CIPN management in practice. The primary aims of this two-phase, pre-posttest study were to explore the impact of a CIPN clinician decision support algorithm on clinicians' frequency of CIPN assessment documentation and adherence to evidence-based management. METHODS: One hundred sixty-two patients receiving neurotoxic chemotherapy (e.g., taxanes, platinums, or bortezomib) answered patient-reported outcome measures on CIPN severity and interference prior to three clinic visits at breast, gastrointestinal, or multiple myeloma outpatient clinics (n = 81 usual care phase [UCP], n = 81 algorithm phase [AP]). During the AP, study staff delivered a copy of the CIPN assessment and management algorithm to clinicians (N = 53) prior to each clinic visit. Changes in clinicians' CIPN assessment documentation (i.e., index of numbness, tingling, and/or CIPN pain documentation) and adherence to evidence-based management at the third clinic visit were compared between the AP and UCP using Pearson's chi-squared test. RESULTS: Clinicians' frequency of adherence to evidence-based CIPN management was higher in the AP (29/52 [56%]) than the UCP (20/46 [43%]), but the change was not statistically significant (p = 0.31). There were no improvements in clinicians' CIPN assessment frequency during the AP (assessment index = 0.5440) in comparison to during the UCP (assessment index = 0.6468). CONCLUSIONS: Implementation of a clinician-decision support algorithm did not significantly improve clinicians' CIPN assessment documentation or adherence to evidence-based management. Further research is needed to develop theory-based implementation interventions to bolster the frequency of CIPN assessment and use of evidence-based management strategies in practice. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03514680 . Registered 21 April 2018.
Asunto(s)
Antineoplásicos/efectos adversos , Toma de Decisiones Clínicas/métodos , Técnicas de Apoyo para la Decisión , Neoplasias/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/diagnóstico , Adulto , Anciano , Algoritmos , Medicina Basada en la Evidencia/normas , Estudios de Factibilidad , Femenino , Adhesión a Directriz/estadística & datos numéricos , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Enfermeras Practicantes/estadística & datos numéricos , Medición de Resultados Informados por el Paciente , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapia , Asistentes Médicos/estadística & datos numéricos , Médicos/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Calidad de Vida , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios/estadística & datos numéricosRESUMEN
The outbreak of the coronavirus disease 2019 (COVID-19) and subsequent need for disease transmission mitigation efforts have significantly altered the delivery of cancer care (e.g., rise of telemedicine), including within the field of integrative oncology. However, little has been described about how National Cancer Institute-Designated Cancer Centers have transformed integrative oncology care delivery in response to the COVID-19 pandemic. The purpose of this commentary is to describe the delivery of integrative oncology clinical services and conduct of research at The Leonard P. Zakim Center for Integrative Therapies and Healthy Living at Dana-Farber Cancer Institute during the COVID-19 pandemic. Clinical services transitioned from an array of in-person appointment-based services, such as acupuncture and massage, and group programs, such as yoga and nutrition seminars to a combination of live-streamed and on-demand virtual group programs and one-on-one virtual appointments for services such as acupressure and self-care massage. Group program volume grew from 2189 in-person program patient visits in the 6 months prior to onset of the COVID pandemic to 16,366 virtual (e.g., live-streamed or on-demand) patient visits in the first 6 months of the pandemic. From a research perspective, two integrative oncology studies, focused on yoga and music therapy, respectively, were transitioned from in-person delivery to a virtual format. Participant accrual to these studies increased after the transition to virtual consent and intervention delivery. Overall, our clinical and research observations at Dana-Farber Cancer Institute suggest that the delivery of virtual integrative oncology treatments is feasible and appealing to patients. Trial Registration: NCT03824860 (Yoga); NCT03709225 (Music Therapy).
Asunto(s)
COVID-19 , Oncología Integrativa , Musicoterapia/métodos , Neoplasias , Telemedicina/métodos , Yoga , COVID-19/epidemiología , COVID-19/prevención & control , Terapias Complementarias/métodos , Terapias Complementarias/tendencias , Humanos , Control de Infecciones , Oncología Integrativa/métodos , Oncología Integrativa/tendencias , National Cancer Institute (U.S.)/estadística & datos numéricos , Neoplasias/psicología , Neoplasias/rehabilitación , Evaluación de Procesos y Resultados en Atención de Salud , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapia , Psicooncología/métodos , SARS-CoV-2 , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia. METHODS: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age. RESULTS: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control. CONCLUSION: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation. TRIAL REGISTRATION: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009.
Asunto(s)
Antineoplásicos/efectos adversos , Autoevaluación Diagnóstica , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapia , Autocuidado/métodos , Encuestas y Cuestionarios , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndromes de Neurotoxicidad/psicología , Síndromes de Neurotoxicidad/terapia , Enfermedades del Sistema Nervioso Periférico/psicología , Calidad de Vida/psicología , Autocuidado/psicología , Autocuidado/normas , Encuestas y Cuestionarios/normas , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: To test a reduced version-CIPN15-of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy scale (QLQ-CIPN20) to establish a possible gold-standard patient-reported outcome measure for chemotherapy-induced peripheral neuropathy (CIPN). METHODS: Using a prospective, longitudinal, case-control design, patients (n = 121) receiving neurotoxic chemotherapy completed the CIPN15 at baseline and 12 weeks and underwent objective neurological assessment using the 5-item Total Neuropathy Score-Clinical (TNSc). Healthy controls (n = 30) completed the CIPN15 once. Structural validity was evaluated using factor analysis. Because a stable factor structure was not found, a sum score was used to evaluate measures of the CIPN15's psychometric properties-reliability, validity, sensitivity, and responsiveness-as follows: internal consistency via Cronbach's α and item-item correlations; test-retest reliability via correlation between 2 CIPN15 scores from each patient; concurrent validity via correlation between CIPN15 and 5-item TNSc scores; contrasting group validity via comparison of CIPN15 scores from patients and healthy controls; sensitivity via descriptive statistics (means, standard deviation, ranges); and responsiveness via Cohen's d effect size. RESULTS: Most patients received single agent oxaliplatin (33.7%), paclitaxel (21.2%), or more than 1 neurotoxic drug concurrently (29.8%). Factor analysis revealed no stable factor structure. Cronbach's α for the CIPN15 sum score was 0.91 (confidence interval [CI] = 0.89-0.93). Test-retest reliability was demonstrated based on strong correlations between the 2 scores obtained at the 12-week time point ( r = 0.86; CI = 0.80-0.90). The CIPN15 and 5-item TNSc items reflecting symptoms (not signs) were moderately correlated ( r range 0.57-0.72): concurrent validity. Statistically significant differences were found between patient and healthy control CIPN15 mean scores ( P < .0001): contrasting group validity. All items encompassed the full score range but the CIPN15 linearly converted sum score did not: sensitivity. The CIPN15 was responsive based on a Cohen's d of 0.52 (CI = 0.25-0.79). CONCLUSION: The sum-scored CIPN15 is reliable, valid, sensitive, and responsive when used to assess taxane- and platinum-induced CIPN.
Asunto(s)
Medición de Resultados Informados por el Paciente , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Ensayos Clínicos como Asunto , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Patients undergoing treatment for cancer commonly experience symptoms such as sleep disturbance, pain, anxiety, depression, and low energy/fatigue (SPADE), subsequently altering physical function and complicating effective symptom management. However, little is known about the frequency, severity, and clustering of SPADE symptoms in individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN). Aims/Design: The purpose of this cross-sectional, secondary analysis was to describe the frequency, severity, and clustering of SPADE symptoms and their association with physical function in individuals with chronic painful CIPN. Participants/Subjects: Sixty individuals with chronic painful CIPN were recruited from five academic and community oncology outpatient center to participate in a randomized controlled pilot trial designed to test the efficacy of a cognitive behavioral therapy-based pain management program. METHODS: Participants completed the 0-10 Average CIPN Pain Numerical Rating Scale and Patient-Reported Outcome Measurement Information System measures for sleep-related impairment, anxiety, depression, fatigue, and pain interference via tablet before being randomly assigned to a study arm. The frequency, severity, and clustering of SPADE symptoms were calculated via descriptive statistics and Partitioning Around Medoids cluster analysis. Spearman rank correlation was performed to determine the association between number of SPADE symptoms and pain interference severity. RESULTS AND CONCLUSIONS: Participants (n = 59) experienced numerous SPADE symptoms. 66.1% of participants experienced at least two SPADE symptoms concurrently. The cluster analysis revealed high (n = 36) and low (n = 23) severity subgroups. There was a moderate correlation (r = 0.48) between the number of SPADE symptoms and pain interference severity. Determining the clustering of SPADE symptoms in individuals with chronic painful CIPN may lead to targeted multifaceted interventions to improve physical function.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias/complicaciones , Enfermedades del Sistema Nervioso Periférico/complicaciones , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Ansiedad/etiología , Estudios Transversales , Depresión/etiología , Fatiga/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor/métodos , Proyectos Piloto , Trastornos del Sueño del Ritmo Circadiano/etiología , Encuestas y Cuestionarios , SíndromeRESUMEN
Lack of activation in self-care can compromise a patient's ability to monitor and manage cancer treatment-related side effects, such as chemotherapy-induced peripheral neuropathy (CIPN). The web-based Carevive® Care Planning System (CPS) was developed to promote evidence-based symptom assessment and treatment by enhancing patients' involvement in their own care. The purpose of this single-arm, pre-test/post-test, prospective study was to examine whether the CPS can promote patient activation in CIPN symptom assessment and management. Seventy-five women with breast cancer receiving neurotoxic chemotherapy were recruited from a Comprehensive Cancer Center. Using standardized neuropathy measures embedded within the CPS, patients reported their CIPN symptoms over three consecutive clinical visits and completed the Patient Activation Measure (PAM) at the first and third visits. Mean changes in PAM scores between visits were compared using repeated measure analysis of covariance, adjusting for age. At baseline, patients were diagnosed with cancer within the past year (94.7%), highly activated (85% Level III/IV), and had a mean age of 51.3. PAM scores improved significantly from 67.15 (SD = 13.5; range = 47-100) at visit one to 69.29 (SD = 16.18; range = 47-100) (p = 0.02) (n = 62) at visit three. However, patients perceived the CPS to be of minimal value because it solely focused on CIPN and, for many, CIPN was not severe enough to motivate them to seek out symptom management information. Further research is needed to assess the utility of the CPS in promoting activation in the assessment and management of varying cancer treatment-related symptoms.
Asunto(s)
Antineoplásicos/efectos adversos , Participación del Paciente , Enfermedades del Sistema Nervioso Periférico/terapia , Autocuidado/métodos , Adulto , Anciano , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Humanos , Internet , Persona de Mediana Edad , Síndromes de Neurotoxicidad/terapia , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Estudios ProspectivosRESUMEN
PURPOSE: Preliminary evidence suggests that a self-guided cognitive and behaviourally-based pain management intervention (PROSPECT) is effective for chronic painful chemotherapy-induced peripheral neuropathy (CIPN), but its mechanism of action is unknown. The purpose of this secondary analysis was to explore if changes in anxiety, depression, sleep-related impairment, or fatigue mediated improvements in worst pain following PROSPECT in individuals with chronic painful CIPN. METHODS: Sixty participants were randomized to receive self-guided cognitive behavioural pain management (access for eight weeks) or treatment as usual. A seven-day worst CIPN pain diary and the PROMIS measures of anxiety, depression, fatigue, and sleep-related impairment were administered pre/posttest (eight-weeks). Causal mediation analysis was used to quantify mediators of worst pain improvement. RESULTS: None of the hypothesized mediators had a statistically significant effect on worst pain (n=38). IMPLICATIONS: Further research is needed to identify potential mediators of pain intensity that can be targeted by specific cognitive behavioural strategies to improve painful CIPN severity.
RESUMEN
PURPOSE: The aim of this study is to examine and compare with the validated, paper/pencil European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20), the psychometric properties of three electronically administered patient reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN): (1) the two neuropathy items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), (2) the QLQ-CIPN20, and (3) the 0-10 Neuropathy Screening Question (NSQ). METHODS: We employed a descriptive, cross-sectional design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy at an academic hospital. Participants completed the paper/pencil QLQ-CIPN20 and electronic versions of the QLQ-CIPN20, PRO-CTCAE, and NSQ. Internal consistency reliability, intraclass correlation, and concurrent and discriminant validity analyses were conducted. RESULTS: The alpha coefficients for the electronic QLQ-CIPN20 sensory and motor subscales were 0.76 and 0.75. Comparison of the electronic and paper/pencil QLQ-CIPN20 subscales supported mode equivalence (intraclass correlation range >0.91). Participants who reported the presence of numbness/tingling via the single-item NSQ reported higher mean QLQ-CIPN20 sensory subscale scores (p < 0.001). PRO-CTCAE neuropathy severity and interference items correlated well with the QLQ-CIPN20 electronic and paper/pencil sensory (r = 0.76; r = 0.70) and motor (r = 0.55; r = 0.62) subscales, and with the NSQ (r = 0.72; r = 0.44). CONCLUSION: These data support the validity of the electronically administered PRO-CTCAE neuropathy items, NSQ, and QLQ-CIPN20 for neuropathy screening in clinical practice. The electronic and paper/pencil versions of the QLQ-CIPN can be used interchangeably based on evidence of mode equivalence.
Asunto(s)
Antineoplásicos/efectos adversos , Neoplasias/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Calidad de Vida/psicología , Estudios Transversales , Femenino , Humanos , Masculino , Medición de Resultados Informados por el Paciente , Reproducibilidad de los ResultadosRESUMEN
Because numerous barriers hinder the assessment and management of chemotherapy-induced peripheral neuropathy in clinical practice, the Carevive Care Planning System, a novel Web-based platform, was developed to address these barriers. It provides patients an opportunity to report their symptoms before their clinic visit and generates customizable care plans composed of evidence-based management strategies. The purpose of this study was to evaluate patient and provider perspectives of feasibility, usability, acceptability, and satisfaction with the Carevive platform. We used a single-arm, pretest/posttest, prospective design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy and six advanced practice providers from an academic hospital. At three consecutive clinical visits, patients reported their neuropathy symptoms on a tablet via the Carevive system. The Diffusion of Innovations Theory served as an overarching evaluation framework. The Carevive platform was feasible to use. However, patients had higher ratings of usability, acceptability, and satisfaction with the platform than did the providers, who disliked the amount of time required to use the platform and had difficulty logging into Carevive. If issues regarding provider dissatisfaction can be addressed, the Carevive platform may aid in the screening of neuropathy symptoms and facilitate the use of evidence-based management strategies.