Yoga Therapy as an Intervention to Improve Patient-Reported Outcomes Among Adults After Treatment for Cancer: Preliminary Findings From a Trial Using Single-Subject Experimental Design.

BACKGROUND: Cancer is a chronic condition associated with a substantial symptom burden, which can impair recovery after treatment. Investigating interventions with potential to improve self-reported disease and/or treatment effects-known as patient-reported outcomes (PROs)-is paramount to inform cancer care. The objective of this study was to evaluate the effects of a yoga therapy (YT) intervention on key PROs (ie, cancer-related fatigue, anxiety, cognitive function, depression, stress, quality of life [QoL]) among adults after treatment for cancer. METHODS: Data from 20 adults (Mage = 55.74 years, 85% female; Mtime since diagnosis = 2.83 years) who had completed treatment for cancer were analyzed for this study. In this single-subject exploratory experimental study, the YT intervention comprised a 1:1 YT session (ie, 1 participant with 1 yoga therapist) followed by 6 weekly small (ie, 2-3 participants) group YT sessions. Group sessions were facilitated by the same yoga therapist who delivered participants' 1:1 session to ensure an in-depth personalized approach. PROs were assessed before (ie, pre-intervention) and after the 1:1 YT session (ie, during the intervention), as well as after the last group YT session (ie, post-intervention). Hierarchical linear modeling was used to analyze the data. RESULTS: Participants showed improvements in cancer-related fatigue, state anxiety, trait anxiety, perceived cognitive impairments, impacts of perceived cognitive impairments on QoL, and 1 dimension of QoL (ie, functional wellbeing) over time. Notably, cancer-related fatigue and state anxiety increased immediately after the 1:1 session, but showed greater improvements over time afterward (ie, during the intervention phase). No changes were observed for the remaining PROs. CONCLUSION: Although results require confirmation in future trials, this study highlights the importance of continuing to investigate YT as an intervention to enhance important PROs (ie, cancer-related fatigue and state anxiety) after treatment for cancer. More research is needed to identify additional beneficial effects and factors that influence participants' responses to 1:1 and group YT (ie, moderators and mediators). REGISTRATION NUMBER: ISRCTN64763228. DATE OF REGISTRATION: December 12, 2021. This trial was registered retrospectively. URL OF TRIAL REGISTRY RECORD: https://www.isrctn.com/ISRCTN64763228. PUBLISHED PROTOCOL: Brunet, J., Wurz, A., Hussien, J., Pitman, A., Conte, E., Ennis, J. K., . . . & Seely, D. (2022). Exploring the Effects of Yoga Therapy on Heart Rate Variability and Patient-Reported Outcomes After Cancer Treatment: A Study Protocol. Integrative Cancer Therapies, 21, 15347354221075576.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: a double-blind randomised controlled trial.

BACKGROUND: COVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19. METHODS: Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 µg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality. RESULTS: 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes. INTERPRETATION: In this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility. TRIAL REGISTRATION NUMBER: NCT04780061.

Exploring the Effects of Yoga Therapy on Heart Rate Variability and Patient-Reported Outcomes After Cancer Treatment: A Study Protocol.

BACKGROUND: Following cancer treatment, adults commonly report worsened patient-reported outcomes (PROs) such as anxiety, stress, depression, persistent and upsetting cognitive complaints, unrelenting fatigue, and reduced quality of life. Poorer PROs are associated with disrupted autonomic nervous system functioning as measured by heart rate variability (HRV), both of which have been associated with greater morbidity and mortality. Interventions to improve HRV and PROs among adults following cancer treatment are needed. Yoga therapy holds promise as an intervention to improve HRV and PROs. Therefore, we conducted a single-subject exploratory experimental study to investigate the effects of yoga therapy on HRV and specific PROs (ie, cancer-related fatigue, anxiety, cognitive function, depression, stress, quality of life) in adults treated for cancer. To reduce publication bias, improve reproducibility, and serve as a reference for forthcoming reporting of study results, we present the study protocol for this study herein. METHODS: Participants were adults who completed cancer treatment that were recruited from the Ottawa Integrative Cancer Centre. Consenting and eligible participants received one 1:1 yoga therapy session (ie, 1 participant, 1 Yoga Therapist) and 6 weekly group-based yoga therapy sessions (ie, 2-3 participants, 1 Yoga Therapist). Participants completed assessments 7 times: 3 times prior to the program (ie, -6 weeks, -3 weeks, immediately prior to the 1:1 yoga therapy session), immediately following the 1:1 yoga therapy session, prior to the first group-based yoga therapy session, after the last group-based yoga therapy session, and at a 6-week follow-up. Hierarchical linear modeling will be used to test the average effects of the yoga therapy program across participants. DISCUSSION: This study will explore several novel hypotheses, including whether yoga therapy can improve HRV and/or specific PROs among adults treated for cancer acutely (ie, during a 1:1 yoga therapy session) and/or through repeated exposure (ie, after completing 6 weeks of group-based yoga therapy). Although the findings will require confirmation or refutation in future trials, they may provide initial evidence that YT may benefit adults treated for cancer. TRIAL REGISTRATION: ISRCTN registry, ISRCTN64763228. Registered on December 12, 2021. This trial was registered retrospectively. URL of trial registry record: https://www.isrctn.com/ISRCTN64763228.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial.

INTRODUCTION: COVID-19 has caused morbidity, hospitalisations and deaths worldwide. Despite four approved vaccines for COVID-19 in Canada, there is still a need for effective treatments, especially for people in the community. Vaccine efficacy is not 100% and long-term efficacy is still unknown. Furthermore, there are challenges to herd immunity including vaccine hesitancy and underlying conditions preventing vaccination. We aim to explore if the nutrients vitamin C, vitamin D, vitamin K2 and zinc are an effective treatment option for outpatients diagnosed with COVID-19. The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality. METHODS AND ANALYSIS: This study is a two-arm, parallel-group, double-blind, placebo-controlled, phase III randomised controlled trial. 200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital. Overall health will be measured using the EuroQol Visual Assessment Scale; health status will be measured using the EuroQol 5-dimension 5-level questionnaire; symptom severity and duration will be measured using an independently developed questionnaire; analyses will use an area under the curve approach and compare mean scores using unadjusted t tests. Study data will be recorded on electronic case report forms using the Research Electronic Data Capture platform. An independent data safety and monitoring board will perform ongoing review of the study for feasibility and safety. ETHICS AND DISSEMINATION: This study has received ethical approval from the research ethics boards of the Canadian College of Naturopathic Medicine and the Ottawa Health Sciences Network, as well as regulatory approval from the Therapeutic Products Directorate and Natural and Non-Prescription Health Products Directorate of Health Canada. Results will be published in a peer-reviewed scientific journal with open access. TRIAL REGISTRATION NUMBER: NCT04780061.

A Prospective Outcomes Pilot Evaluation of Inspire Now: A Program for People with Lung Cancer.

BACKGROUND: Lung cancer is the leading cause of cancer mortality in Canada, yet patients are often under-supported. A six-week program called Inspire Now, created to address unmet supportive care needs, was evaluated in this study. Feasibility and preliminary outcomes were assessed in order to inform future changes to the program. OBJECTIVES: (1) Assess the feasibility of the program and its evaluation; (2) pilot the collection of patient-reported outcomes; (3) identify outcomes that may be positively influenced; and (4) inform program modifications. METHODS: Participants were recruited from the first session of Inspire Now for an observational pilot study. The primary outcome was feasibility. Secondary outcomes included within-person changes in Functional Assessment of Cancer Therapy - Lung (FACT-L) and Measure Yourself Concerns and Wellbeing (MYCaW), and program satisfaction and qualitative experiences of participants and facilitators through internally-developed questionnaires and semi-structured interviews. Analysis was primarily descriptive, within person changes in FACT-L and MYCaW were analyzed using the Wilcoxon signed-rank test and qualitative data was assessed for common themes. RESULTS: The program and its evaluation were feasible; 8 of 9 (89%) participants consented to the study, median attendance was 6 of 6 sessions (IQR 4.5-6), and questionnaire completion was 100% at baseline and 75% at follow-up. There were clinically meaningful improvements in MYCaW concern 1 (-1.2, 95% CI -2.0 to -0.4) and overall wellbeing (-0.9, 95% CI -2.1 to 0.4). Seven of eight FACT-L sub-sections trended toward improvement, with absolute changes ranging from -1.7 to 10.8%. Participant feedback was overwhelmingly positive; group support and social interactions were highly valued. CONCLUSIONS: The group intervention for people with lung cancer was feasible to both run and evaluate. Participants responded positively to the program. Findings will inform changes to future sessions and an analysis of multiple sessions is planned.

[Creation of a data bank for sustainability of leprosy post elimination]. / Criação de banco de dados para sustentação da pós-eliminação em hanseníase.

São José do Rio Preto reached the World Health Organization goal eliminating leprosy as a Public Health problem in the year 2006, with a prevalence of 0.79/10,000 inhabitants. In order to warrant reliable information to promote management measures that keep this status, the aim of this study was to create a leprosy data bank in the city with information from 1998 to 2006. A data collection protocol was used and it contained 74 clinical-epidemiological variables that were gathered from primary and secondary sources. This work was initiated with 442 cases registered in the municipal control program database, from those 168 were excluded and 85 were inserted. There were 24 cases not notified in the National Information System (SINAN). The 74 variables collected will allow further studies about themes: epidemiological profiles, household contacts control, reactions and deficiencies, and others. The difficulties faced during the elaboration of the database were related to decoding medical files data and inconsistency in the SINAN. The frequent mistakes while entering the data weaken the information system and difficult the plan of precise actions regarding health. These facts are relevant to the quality of attention and the maintenance of the leprosy elimination status.

Criação de banco de dados para sustentação da pós-eliminação em hanseníase / Creation of a data bank for sustainability of leprosy post elimination

São José do Rio Preto atingiu o parâmetro da Organização Mundial de Saúde de eliminação da hanseníase como problema de saúde pública em 2006, com prevalência de 0,79/10.000 habitantes. Para garantir informações fidedignas que permitam medidas gerenciais e manutenção deste quadro, o objetivo do estudo foi criar um banco de dados da hanseníase do município, no período de 1998 a 2006. Utilizou-se protocolo para coleta de dados de 74 variáveis clínico-epidemiológicas encontradas em fontes primárias e secundárias. Iniciou-se o trabalho com 442 casos existentes nas informações de dados do programa de controle do município; destes, 168 foram excluídos e 85 inseridos; 24 não haviam sido notificados no Sistema de Informação de Agravos de Notificação (SINAN). As 74 variáveis coletadas possibilitarão estudo posterior de temas, como o perfil epidemiológico, controle de comunicantes, reações, deficiências, entre outros. As dificuldades encontradas na elaboração do banco foram em relação à decodificação de dados dos prontuários e inconsistências nas anotações do SINAN. Os erros no registro dos dados ocorrem com frequência, debilitando informações e dificultando o planejamento das ações na área, fatores importantes para qualidade do atendimento e sustentação da eliminação da hanseníase.

São José do Rio Preto reached the World Health Organization goal eliminating leprosy as a Public Health problem in the year 2006, with a prevalence of 0.79/10,000 inhabitants. In order to warrant reliable information to promote management measures that keep this status, the aim of this study was to create a leprosy data bank in the city with information from 1998 to 2006. A data collection protocol was used and it contained 74 clinical-epidemiological variables that were gathered from primary and secondary sources. This work was initiated with 442 cases registered in the municipal control program database, from those 168 were excluded and 85 were inserted. There were 24 cases not notified in the National Information System (SINAN). The 74 variables collected will allow further studies about themes: epidemiological profiles, household contacts control, reactions and deficiencies, and others. The difficulties faced during the elaboration of the database were related to decoding medical files data and inconsistency in the SINAN. The frequent mistakes while entering the data weaken the information system and difficult the plan of precise actions regarding health. These facts are relevant to the quality of attention and the maintenance of the leprosy elimination status.

Situação epidemiológica da hanseníase no município de São José do Rio Preto, SP, Brasil / Epidemiological situation of leprosy in the city of São José do Rio Preto, SP, Brazil

Introdução: A hanseníase persiste, até o momento, como um problema de saúde pública. O objetivo desta pesquisa foi descrever o perfil epidemiológico da doença, em SJRio Preto, no período de 1998 a 2006. Materiais e Métodos: Trata-se de um estudo descritivo, transversal cuja coleta de dados foi realizada mediante consultanos prontuários. Resultados: Das 359 pessoas estudadas, a maioria realizou tratamento no Núcleo de Gestão Ambulatorial (72,7%). 59,1% foram classificados como multibacilares e 73,8% tinham a baciloscopia negativa; idade média de 53 anos (dp16); 49,6% apresentaram episódio reacional; 9,7% conheciam a fonte de contágio;10,6% apresentaram efeitos colaterais aos medicamentos; 82% estavam em alta; 85,5% foram avaliados eacompanhados em prevenção de incapacidades no diagnóstico e destes 85,7% apresentaram Grau zero (semincapacidades). Discussão: Ações de vigilância epidemiológica precisam ser intensificadas e a descentralização discutida com autoridades, com o propósito de incrementar a detecção precoce, o controle de comunicantese prevenção de deficiências. Conclusão: Apesar da prevalência no município estar dentro dos parâmetros de eliminação como problema de saúde pública recomendados pela OMS, a maioria dos casos ainda é diagnosticada na forma polarizada.

Introduction: Leprosy persists until the moment as a problem of public health. The objective of this study was to describe the epidemiological profile of leprosy in São José do Rio Preto from 1998 to 2006. Materials and Methods: This transversal descriptive study utilized data that were collected from the patients’ medical records. Results: During the period analyzed, 359 patients were studied. The majority (72.7%) was treated at "Núcleo de Gestão Assistencial (NGA 60)", a health care service", 59.1% were multibacillary, and 73.8%presented a negative bacillary index. Mean age was 53 years ± 16 SD. The clinical data of the 359 patients areas follows: 49.6% presented reactional episodes, 9.7% were aware of their source of infection, 10.6% showed collateral effects to medications, and 82% are cured. From those patients (85.5%) who were evaluated for incapacities 85.7% presented grade zero (no incapacity). Discussion: Leprosy epidemiological surveillance needs to be intensified and the decentralization discussed with health authorities in order to increase early detection and evaluate contacts to prevent disabilities. Conclusion: Despite the prevalence being within the WHO recommended elimination parameters as a Public Health problem, most cases are still diagnosed in the polarized forms in São José do Rio Preto.