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1.
JCO Glob Oncol ; 10: e2400043, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38959449

RESUMO

PURPOSE: The study aims to explore unmet social needs and sources of financial toxicities in patients as noted by health care professionals and researchers in cancer supportive care, shedding light on potential health disparities. METHODS: In this cross-sectional survey, we anonymously surveyed active members of the Multinational Association of Supportive Care in Cancer (MASCC). The survey, structured in three sections, included questions regarding the routine assessment of social needs during patient consultations, sociodemographic aspects, factors influencing financial toxicity (FT), perceived support for managing FT, and available/desirable resources. RESULTS: A total of 218 MASCC members were included, predominantly from high-income countries (HIC, 73.4%), with many age 41-60 years (56.5%) and female (56.9%). Drug/treatment cost and insurance coverage were the main sources for FT among the HIC, whereas participants from low-middle-income countries (LMIC) considered transportation cost, loss of employment because of cancer diagnosis, and unavailability of return-to-work services as the top three sources of FT. Respondents from LMIC (adjusted odds ratio [aOR], 3.01 [95% CI, 1.15 to 7.93]) and physicians (aOR, 2.67 [95% CI, 1.15 to 6.21]) were more likely to routinely assess financial coverages. Socioeconomic status was consistently ranked as one of the top three sources of financial toxicities by participants from LMIC (34%), HIC excluding the United States (38%), those who do not self-identify as racial/ethnic minority (36%), and physicians (40%). CONCLUSION: This global survey of health care professionals and researchers in HIC and LMIC revealed varying approaches to assessing financial coverage and social needs. Socioeconomic status emerged as a consistent concern across countries, affecting financial toxicities. The study highlights the need for tailored approaches and improved resource visibility while emphasizing clinicians' pivotal role in addressing financial aspects of cancer care.


Assuntos
Neoplasias , Humanos , Neoplasias/economia , Neoplasias/terapia , Feminino , Estudos Transversais , Masculino , Pessoa de Meia-Idade , Adulto , Inquéritos e Questionários
2.
J Cancer Educ ; 39(4): 445-454, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38724720

RESUMO

Providing cost-effective, comprehensive survivorship care remains a significant challenge. Breast cancer survivors (BCS) who have limited income and are from marginalized racial and ethnic groups experience a worse quality of life and report higher distress. Thus, innovative care models are required to address the needs of BCS in low resource settings. Group medical visits (GMV), utilized in chronic disease management, are an excellent model for education and building skills. This single-arm intervention study was conducted at a public hospital in California. GMVs consisted of five 2-h weekly sessions focused on survivorship care planning, side effects of treatment and prevention, emotional health, sexual health, physical activity, and diet. The patient navigators recruited three consecutive GMV groups of six English-speaking BCS (N = 17). A multidisciplinary team delivered GMVs, and a patient navigator facilitated all the sessions. We used attendance rates, pre- and post-surveys, and debriefing interviews to assess the feasibility and acceptability of the intervention. We enrolled 18 BCS. One participant dropped out before the intervention started, 17 BCS consistently attended and actively participated in the GMV, and 76% (13) attended all planned sessions. Participants rated GMVs in the post-survey and shared their support for GMVs in debriefing interviews. The BCS who completed the post-survey reported that GMVs increased their awareness, confidence, and knowledge of survivorship care. GMVs were explicitly designed to address unmet needs for services necessary for survivorship care but not readily available in safety net settings. Our pilot data suggest that patient-navigator-facilitated GMVs are a feasible and acceptable model for integrating survivorship care in public hospitals.


Assuntos
Neoplasias da Mama , Sobreviventes de Câncer , Estudos de Viabilidade , Provedores de Redes de Segurança , Humanos , Neoplasias da Mama/terapia , Neoplasias da Mama/psicologia , Feminino , Sobreviventes de Câncer/psicologia , Pessoa de Meia-Idade , Qualidade de Vida , Sobrevivência , Aceitação pelo Paciente de Cuidados de Saúde , California , Idoso , Adulto , Consultas Médicas Compartilhadas
3.
JCO Oncol Pract ; : OP2300482, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38709984

RESUMO

Despite advances in clinical cancer care, cancer survivors frequently report a range of persisting issues, unmet needs, and concerns that limit their ability to participate in life roles and reduce quality of life. Needs assessment is recognized as an important component of cancer care delivery, ideally beginning during active treatment to connect patients with supportive services that address these issues in a timely manner. Despite the recognized importance of this process, many health care systems have struggled to implement a feasible and sustainable needs assessment and management system. This article uses an implementation science framework to guide pragmatic implementation of a needs assessment clinical system in cancer care. According to this framework, successful implementation requires four steps including (1) choosing a needs assessment tool; (2) carefully considering the provider level, clinic level, and health care system-level strengths and barriers to implementation and creating a pilot system that addresses these factors; (3) making the assessment system actionable by matching needs with clinical workflow; and (4) demonstrating the value of the system to support sustainability.

4.
Cardiooncology ; 10(1): 28, 2024 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-38760873

RESUMO

BACKGROUND: Breast cancer survivors are disproportionately at risk for cardiovascular disease; exercise-based interventions may improve cardiovascular health. The objective of this formative research is to better understand the needs of patients and barriers to participation in an adapted cardiac rehabilitation program for diverse breast cancer survivors in an urban safety net setting. METHODS: We recruited 30 participants (10 English-speaking, 10 Spanish-speaking, and 10 Cantonese-speaking) who had received treatment with curative intent for breast cancer from an urban safety net hospital between November 9, 2021, to August 30, 2022. Participants completed surveys and interviews about perspectives on health behaviors and participating in an adapted cardiac rehabilitation program. Interviews were qualitatively analyzed using rapid template analysis with pre-selected constructs from the Theory of Planned Behavior, Unified Theory of Acceptance and Use of Technology, and Consolidated Framework for Implementation Research, as well as emergent codes. We developed a Participant User Journey for a program based on responses and conducted human-centered design sessions with 8 participants to iteratively revise the Participant User Journey. RESULTS: Among 30 participants, mean age was 56.7 years (standard deviation [SD] 10.2) with 100% female sex assigned at birth; 1 participant withdrew before completing study procedures. Most participants had limited health literacy (18/29, 62%). Mean body mass index was 31.4 (SD 8.3), 21/29 (72%) had blood pressure below 140/90 mmHg, and 12/29 (41%) had blood pressure below 130/80. Mean 6-minute walk distance was 384.9 meters (SD 78.3). The desired benefits of a program included healthy living and prevention of cancer recurrence. Barriers to participation included motivation, social support, transportation, and concerns about exercise safety. Participants emphasized the need for practicality, such as fitting physical activity into daily life and nutrition support, including recipes and shopping lists. Trusted experts and cultural and language concordance were viewed as important aspects of the program. CONCLUSIONS: Through participant interviews and human-centered design sessions, we developed the HEART-ACT program, a 12-week multi-disciplinary program addressing physical activity, nutrition, emotional well-being, cardiovascular risk, survivorship, and other components if indicated (e.g., tobacco cessation). Future research will test the effects of this program on patient-centered outcomes.

5.
Support Care Cancer ; 32(3): 205, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38433160

RESUMO

Equity, diversity, and inclusion (EDI) are essential for healthcare organizations since they allow for the development of programs and initiatives that bring together diverse perspectives and knowledge. Global multidisciplinary organizations, such as the Multinational Association for Supportive Care in Cancer (MASCC), need to understand the perspective of their members regarding EDI to identify opportunities to enhance diversity and inclusiveness and to better meet the needs of members from different backgrounds and resources. The MASCC Health Disparities Committee designed a survey to identify issues related to disparities faced by MASCC members when providing supportive care to patients with cancer and to examine the EDI landscape within the organization. Here, we report results related to EDI initiatives within the organization. Two-hundred and eighteen MASCC members responded to the survey (response rate 10.2%). The results indicated that respondents were generally satisfied with how MASCC manages leadership, membership, and organization-related EDI issues. Opportunities for improvement noted by respondents included developing strategies to foster a more diverse membership, improving communication regarding diversity in the organization, and increasing EDI content in educational sessions and publications. The results of this survey represent the first attempt at understanding how to improve EDI within MASCC and will be utilized to guide further initiatives and programs.


Assuntos
Prática de Grupo , Neoplasias , Humanos , Diversidade, Equidade, Inclusão , Comunicação , Escolaridade , Neoplasias/terapia
7.
J Cancer Educ ; 38(3): 845-853, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-35829986

RESUMO

As the number of cancer survivors continues to increase and given the shortage of oncology clinicians in safety net health care settings, primary care providers (PCPs) in these settings will increasingly provide cancer survivorship care. In order to ensure equitable care for low-income and underserved breast and colon cancer survivors, it is essential to understand the safety-net PCPs' perspective. We conducted semi-structured, in-depth qualitative interviews with 11 PCPs working in a safety-net health care system to identify their needs in caring for cancer survivors. Interviews were audio-recorded and professionally transcribed. Two coders independently coded the interviews and conducted regular meetings until we reached consensus on the results. Analysis was based in grounded theory and performed using the constant comparative method. Thematic analysis identified six themes as follows: (1) Cancer survivorship care can be integrated with the whole person and chronic disease care management that occurs in primary care; (2) PCPs' perceptions regarding patients' survivorship care needs and their confidence in meeting those needs; (3) preference for a shared care model; (4) coordination of care; (5) PCPs' need for survivorship care education and training; and (6) unique issues involved in the care of older cancer survivors. PCPs in the safety-net believe that providing comprehensive survivorship care requires coordination of care through the cancer continuum. Tools like checklists, electronic health records-based communication, and convenient electronic consultations with cancer specialists would enhance the quality of survivorship care. Respondents advocate the inclusion of survivorship care education in medical education. The continuity of care with PCPs means that they play a particularly important role in the care of older cancer survivors.


Assuntos
Sobreviventes de Câncer , Neoplasias do Colo , Médicos de Atenção Primária , Humanos , Neoplasias do Colo/terapia , Atenção Primária à Saúde
8.
Curr Epidemiol Rep ; 9(1): 10-21, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35342686

RESUMO

Purpose of Review: Cancer incidence and mortality are decreasing, but inequities in outcomes persist. This paper describes the San Francisco Cancer Initiative (SF CAN) as a model for the systematic application of epidemiological evidence to reduce the cancer burden and associated inequities. Recent Findings: SF CAN is a multi-institutional implementation of existing evidence on the prevention and early detection of five common cancers (i.e., breast, prostate, colorectal, liver, and lung/tobacco-related cancers) accounting for 50% of cancer deaths in San Francisco. Five Task Forces follow individual logic models designating inputs, outputs, and outcomes. We describe the progress made and the challenges faced by each Task Force after 5 years of activity. Summary: SF CAN is a model for how the nation's Comprehensive Cancer Centers are ideally positioned to leverage cancer epidemiology for evidence-based initiatives that, along with genuine community engagement and multiple stakeholders, can reduce the population burden of cancer.

9.
Lymphat Res Biol ; 20(1): 39-47, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-33761290

RESUMO

Background: Lymphedema (LE) is a significant clinical problem for breast cancer survivors. While the water displacement test and circumferential assessment using a tape measure (TM) are common methods to assess differences in arm volumes, faster and more reliable methods are needed. Study purposes, in breast cancer survivors (n = 294), were to compare the average total arm volumes and interlimb volume ratios for women with and without a history of LE, using a TM and three-dimensional (3D), whole-body surface scanner (3D scan); compare the level of agreement between arm volumes and interlimb volume ratios obtained using the two devices; and evaluate the percent agreement between the two measures in classifying cases of LE using three accepted thresholds. Methods and Results: Measurements were done using a spring-loaded TM and Fit3D ProScanner. Paired t-tests and Bland-Altman analyses were used to achieve the study aims. For circumference and volume comparisons, compared with the 3D scan, values obtained using the TM were consistently smaller. In terms of level of agreement, the Bland-Altman analyses demonstrated large biases and wide limits of agreement for the calculated arm volumes and volume ratios. In terms of the classification of caseness, using the 200-mL interlimb volume difference criterion resulted in 81.6% overall agreement; using the >10% volume difference between the affected and unaffected arms resulted in 78.5% overall agreement; and using the volume ratio ≥1.04 criterion resulted in 62.5% overall agreement. For all three accepted threshold criteria, the percentage of cases was significantly different between the TM and 3D scan techniques. Conclusions: The 3D technology evaluated in this study has the potential to be used for self-initiated surveillance for LE. With improvements in landmark identification and software modifications, it is possible that accurate and reliable total arm volumes can be calculated and used for early detection.


Assuntos
Linfedema Relacionado a Câncer de Mama , Neoplasias da Mama , Sobreviventes de Câncer , Linfedema , Braço/diagnóstico por imagem , Linfedema Relacionado a Câncer de Mama/diagnóstico por imagem , Linfedema Relacionado a Câncer de Mama/etiologia , Neoplasias da Mama/complicações , Neoplasias da Mama/diagnóstico por imagem , Feminino , Humanos , Linfedema/diagnóstico por imagem , Linfedema/etiologia
10.
Support Care Cancer ; 30(2): 1007-1010, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34668075

RESUMO

Telehealth use has increased in the setting of the COVID-19 pandemic. However, there are disparities in telehealth use based on age, income, race/ethnicity, low health, digital literacy, and limited English proficiency. There are multilevel barriers to telehealth use at the patient, health systems, telehealth portal, and policy levels. To ensure equity in telehealth services and to leverage these services to maximize the reach of health care services, concerted efforts are needed to design telehealth tools and workflows. It should include reimbursement for staff training, patient education, and technical support needed for telehealth use. Furthermore, ongoing monitoring and responsive modifications in the use of telehealth services are needed to promote telehealth equity.


Assuntos
COVID-19 , Telemedicina , Etnicidade , Humanos , Pandemias , SARS-CoV-2
11.
Lymphat Res Biol ; 20(4): 391-397, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-34793255

RESUMO

Background: In patients with lymphedema (LE), in addition to hand dominance, between-group comparisons of interlimb soft tissue differences need to account for differences in whole-body adiposity, measured directly by dual energy X-ray absorptiometry (DXA) or indirectly by body mass index. No study has evaluated the effects of hand dominance and whole-body adiposity on limb composition in patients with LE. This study's purpose was to compare soft tissue composition of affected and unaffected limbs of women with breast cancer, who did and did not have LE, controlling for dominance and percent body fat. Methods and Results: Whole-body DXA scans were acquired and included measures of percent body fat, upper limb total mass, upper limb fat mass, and upper limb fat-free mass. Participants were classified into one of three groups: women without LE; women with only subjective LE; and women with objective signs of LE at the time of assessment. Differences among the LE groups were evaluated using analysis of variance (ANOVA) and Chi-square analyses. Analysis of covariance (ANCOVA) was used to control for percent body fat and for the affected limb dominance. Compared to women without LE, women with objective signs of LE have greater total limb mass, fat mass, and fat-free mass in their affected limbs, independent of affected side dominance and percent body fat. In addition, the interlimb differences in total mass, fat mass, and fat-free mass were greater for the women with objective signs of LE, compared to the other two groups. Conclusions: DXA is useful in identifying soft tissue changes in patients with LE. Given that limb circumferences measure only changes in limb volume and that bioimpedance provides estimates of extracellular fluid, DXA has the advantage of being able to estimate the volumes of specific tissues in the limb.


Assuntos
Neoplasias da Mama , Sobreviventes de Câncer , Linfedema , Absorciometria de Fóton/métodos , Tecido Adiposo/diagnóstico por imagem , Composição Corporal , Neoplasias da Mama/complicações , Neoplasias da Mama/diagnóstico por imagem , Feminino , Humanos , Linfedema/diagnóstico por imagem , Linfedema/etiologia
12.
Cancer Control ; 28: 10732748211038734, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34657452

RESUMO

PURPOSE: The current number of breast cancer survivors (BCS) in the United States is approximately 3.8 million, and this number is further expected to increase with improvement in treatments. Survivorship care plans (SCPs) are patient-centered tools that are designed to meet cancer survivors' informational needs about their treatment history, recommended health care, and health maintenance. However, the data on SCP benefits remain uncertain, especially in low-income and racial and ethnic minority cancer survivors. Patient navigation is an effective intervention to improve patient adherence and experience of interdisciplinary breast cancer treatment. OBJECTIVES: This study sought to understand the role of lay patient navigators (LPN) in survivorship care planning for BCS in safety-net settings. METHODS: This study is a mixed methods pilot randomized clinical trial to understand the role of patient navigation in cancer survivorship care planning in a public hospital. We invited BCS who had completed active breast cancer treatment within 5 years. LPNs discussed survivorship care planning and survivorship care-related issues with BCS in the intervention arm over a 6-month intervention period and accompanied patients to their primary care appointment. LPNs also encouraged survivors to discuss health care issues with oncology and primary care providers. The primary objective was to assess BCS' health-related quality of life (HRQOL). The secondary objectives were self-efficacy and implementation. We assessed implementation with 45-60-min semi-structured interviews with 15 BCS recruited from the intervention arm and 60-min focus groups with the oncologists and separately with LPNs. RESULTS: We enrolled 40 patients, 20 randomized to usual care and 20 randomized to LPN navigation. We did not find a statistically significant difference between the two arms in HRQOL. There was also no difference in self-efficacy between the two arms. Qualitative analysis identified implementation barriers to intervention that may have contributed to less effective intervention. IMPLICATIONS FOR CANCER SURVIVORS: Future survivorship care planning interventions need to consider: Cancer survivors' needs and preferences, the need for dedicated resources, and the role of electronic health records in survivorship care plan delivery.


Assuntos
Neoplasias da Mama/terapia , Sobreviventes de Câncer , Minorias Étnicas e Raciais , Assistência Centrada no Paciente/organização & administração , Provedores de Redes de Segurança/organização & administração , Sobrevivência , Feminino , Nível de Saúde , Humanos , Saúde Mental , Navegação de Pacientes/organização & administração , Desempenho Físico Funcional , Pobreza , Qualidade de Vida , Participação Social , Fatores Sociodemográficos , Estados Unidos
15.
Indian J Dermatol ; 66(3): 291-296, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34446953

RESUMO

BACKGROUND: The association of Vitamin D (vit.D) and Interleukin 17 (IL-17) with acne vulgaris is uncertain in spite of induction of IL-17 by Propionibacterium acnes (P. acnes) and the role of vit.D in various inflammatory skin disorders including acne. The objectives of present study were to evaluate the levels of serum 25-hydroxyvitamin D3 [25(OH)D] and IL-17 in acne patients and age- and sex-matched controls and to compare them with the severity of acne as measured by Global Acne Grading System (GAGS). METHODS: The study included 50 patients of acne and 30 healthy controls. Serum 25(OH) D and IL-17 levels were measured using chemiluminescence immunoassay (CLIA) and enzyme-linked immunosorbent assay (ELISA), respectively. RESULTS: Vitamin D deficiency was detected in 28% of patients with acne but only in 6.7% of the healthy controls (P value 0.022). The levels of 25(OH)D were inversely associated with the severity of acne (P < 0.001). The mean serum IL-17 levels were significantly raised (P < 0.001) in acne patients (8.215 ± 5.33 pg/mL) as compared to controls (2.486 ± 2.12 pg/mL). A significant rise in levels of IL-17 was observed with the severity of acne (P < 0.001). Further, a highly significant negative correlation (Correlation Coefficient: -0.668) was noted between serum IL-17 and 25(OH) D levels along with disease severity in acne patients (P value < 0.001). CONCLUSIONS: Raised IL-17 levels in acne correlate negatively with vit.D deficiency and both are significantly more prevalent in patients with acne as compared to healthy controls.

16.
Am Soc Clin Oncol Educ Book ; 41: 1-8, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33830828

RESUMO

Notable barriers exist in the delivery of equitable care for all patients with cancers. Social determinants of health at distal, intermediate, and proximal levels impact cancer care. Patient navigation is a patient-centered intervention that functions across these overlapping determinants to increase access to cancer services throughout the cancer care continuum. There is a need to standardize patient navigation training while remaining responsive to local contexts of care and a need to implement patient navigation programs with a health equity lens to address cancer care inequities.


Assuntos
Neoplasias , Navegação de Pacientes , Equidade em Saúde , Humanos , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Neoplasias/terapia
17.
Lymphat Res Biol ; 19(6): 553-561, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33567232

RESUMO

Background: While supine bioimpedance devices are used to evaluate for lymphedema (LE), stand-on devices are gaining popularity. Because research on differences in bioimpedance values between the two devices is limited, this study's purposes were to: (1) determine the average upper limb impedance values and inter-limb ratios for women who self-reported having (n = 34) or not having (n = 61) a history of LE, using a single-frequency supine device and a multifrequency stand-on device; (2) compare the level of agreement in inter-limb impedance ratios between the two devices; evaluate the percent agreement between the two devices in classifying cases of LE using established supine thresholds; and evaluate the percent agreement in classifying cases of LE between the supine device using previously established supine thresholds and the stand-on device using two published standing thresholds. Methods and Results: Bioimpedance measures were done using the two devices. For the entire sample, absolute impedance values for both the affected and unaffected limbs were significantly higher for the stand-on device in women with and without LE. Impedance values for the two methods were highly correlated. Bland-Altman analysis determined that for the entire range of impedance ratios the values for the two devices could not be used interchangeably. Conclusions: Findings suggest that the stand-on device can be a useful and valid tool to assess for LE. However, because agreement is not perfect, values obtained from the two devices should not be used interchangeably to evaluate for changes in impedance ratios, particularly for ratios of >1.20.


Assuntos
Linfedema Relacionado a Câncer de Mama , Neoplasias da Mama , Linfedema , Linfedema Relacionado a Câncer de Mama/diagnóstico , Linfedema Relacionado a Câncer de Mama/etiologia , Neoplasias da Mama/complicações , Neoplasias da Mama/diagnóstico , Impedância Elétrica , Feminino , Humanos , Linfedema/diagnóstico , Linfedema/etiologia , Extremidade Superior
18.
J Cancer Educ ; 36(5): 981-989, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-32128714

RESUMO

Survivorship care plans (SCPs) serve to communicate critical information needed for cancer survivors' long-term follow-up care. The extent to which SCPs are tailored to meet the specific needs of underserved patient populations is understudied. To fill this gap, this study aimed to assess the content and communication appropriateness of SCPs collected from diverse healthcare settings. We analyzed collected SCPs (n = 16) for concordance with Institute of Medicine (IOM) recommendations for SCP content and for communication appropriateness using the Suitability Assessment of Materials (SAM) instrument. All plans failed to incorporate all IOM criteria, with the majority of plans (n = 11) incorporating less than 60% of recommended content. The average reading grade level of all the plans was 14, and only one plan received a superior rating for cultural appropriateness. There is significant variation in the format and content of SCPs used in diverse hospital settings and most plans are not written at an appropriate reading grade level nor tailored for underserved and/or minority patient populations. Co-designing SCPs with diverse patient populations is crucial to ensure that these documents are meeting the needs and preferences of all cancer survivors.


Assuntos
Sobreviventes de Câncer , Neoplasias , Atenção à Saúde , Humanos , Neoplasias/terapia , Planejamento de Assistência ao Paciente , Sobreviventes , Sobrevivência
20.
JAMA Netw Open ; 3(7): e2010874, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32678452

RESUMO

Importance: Sickle cell disease (SCD) is characterized by chronic pain and episodic acute pain caused by vasoocclusive crises, often requiring high doses of opioids for prolonged periods. In humanized mouse models of SCD, a synthetic cannabinoid has been found to attenuate both chronic and acute hyperalgesia. The effect of cannabis on chronic pain in adults with SCD is unknown. Objective: To determine whether inhaled cannabis is more effective than inhaled placebo in relieving chronic pain in adults with SCD. Design, Setting, and Participants: This pilot randomized clinical trial included participants with SCD with chronic pain admitted to a single inpatient clinical research center for 2 separate 5-day stays from August 2014 to April 2017. Participants inhaled either vaporized cannabis (4.4% Δ-9-tetrahydrocannabinol to 4.9% cannabidiol) 3 times daily or vaporized placebo cannabis. Pain and pain interference ratings using the Brief Pain Inventory were assessed throughout each 5-day period. Participants with SCD and chronic pain on stable analgesics were eligible to enroll. A total of 90 participants were assessed for eligibility; 56 participants were deemed ineligible, and 34 participants were enrolled. Of these, 7 participants dropped out before randomization. Of 27 randomized participants, 23 completed both treatment arms of the crossover study and were included in the final per protocol analysis. Data analysis was completed in June 2019, with the sensitivity analysis conducted in April 2020. Interventions: Inhalation of vaporized cannabis plant (4.4% Δ-9-tetrahydrocannbinol to 4.9% cannabidiol) or placebo cannabis plant using a vaporizer 3 times daily for 5 days. Main Outcomes and Measures: Daily pain assessed with visual analog scale and Brief Pain Inventory. Results: A total of 23 participants (mean [SD] age, 37.6 [11.4] years; 13 [56%] women) completed the trial. The mean (SD) difference in pain rating assessment between the cannabis and placebo groups was -5.3 (8.1) for day 1, -10.9 (7.0) for day 2, -16.5 (9.2) for day 3, -8.9 (6.7) for day 4, and -8.2 (8.1) for day 5; however, none of these differences were statistically significant. There was no statistically significant mean (SD) difference in pain interference ratings between cannabis and placebo between days 1 and 5 for interference in general activities (day 1: 0.27 [0.35]; day 5: -1.0 [0.5]), walking (day 1: 0.14 [0.73]; day 5: -0.87 [0.63]), sleep (day 1: 0.59 [0.74]; day 5: -1.3 [0.8]), or enjoyment (day 1: 0.23 [0.69]; day 5: -0.91 [0.48]), but there was a statistically significant mean (SD) difference in decrease in interference with mood (day 1: 0.96 [0.59]; day 5: -1.4 [0.6]; P = .02). No differences in treatment-related adverse effects were observed. Use of concomitant opioids was similar during both treatment periods. Conclusions and Relevance: This randomized clinical trial found that, compared with vaporized placebo, vaporized cannabis did not statistically significantly reduce pain and associated symptoms, except interference in mood, in patients with SCD with chronic pain. Trial Registration: ClinicalTrials.gov Identifier: NCT01771731.


Assuntos
Analgésicos/normas , Anemia Falciforme/tratamento farmacológico , Maconha Medicinal/normas , Manejo da Dor/normas , Administração por Inalação , Adulto , Analgésicos/uso terapêutico , Anemia Falciforme/psicologia , California , Estudos Cross-Over , Feminino , Humanos , Masculino , Maconha Medicinal/uso terapêutico , Pessoa de Meia-Idade , Manejo da Dor/métodos , Manejo da Dor/estatística & dados numéricos , Medição da Dor/métodos , Projetos Piloto
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