Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancer caregivers: A randomized controlled trial.

Caregiving stress is a risk factor for cardiometabolic disease. Therefore, integrating cardiometabolic biomarkers into caregiving research provides a more comprehensive assessment of an individual's health and response to an intervention. The objective of this study was to examine the effects of a yoga-based stress reduction intervention on stress, psychological outcomes, and cardiometabolic biomarkers in cancer caregivers. This prospective randomized controlled trial enrolled family caregivers of adult patients who underwent an allogeneic HSCT at the National Institutes of Health (NIH) Clinical Center. All subjects received usual care education. Participants in the intervention group received an Iyengar yoga intervention self-administered over six weeks using an audio recording file. The primary outcome was perceived stress (measured using the NIH toolbox Perceived Stress). The secondary outcomes were psychological factors (depression and anxiety measured using PROMIS® Depression and Anxiety), and cardiometabolic biomarkers measured by nuclear magnetic resonance spectroscopy. A total of 50 family caregivers (mean [SD] age, 44.9 [15.2] years; 42 [84.0%] women) were randomized, 25 to the intervention group and 25 to the control group. No group differences were noted in stress, depression, and anxiety. Significant interaction effects between group and time were found in large TRL-P (F(1,43) = 10.16, p = 0.003) and LP-IR (F(1,42) = 4.28, p = 0.045). Post-hoc analyses revealed that the levels of large TRL-P (mean difference = 1.68, CI = [0.86, 2.51], p< .001) and LP-IR (mean difference = 5.67, CI = [1.15, 10.18], p = 0.015) significantly increased over time in the control group but while remained stable in the intervention group (mean difference = -0.15, CI = [-0.96, 0.66], p = 0.718; mean difference = -0.81, CI = [-5.22, 3.61], p = 0.714, respectively). Even when perceptions of psychological distress remain unchanged, incorporating gentle yoga poses and breathing exercises may reduce the risk of cardiometabolic disease in caregivers by inhibiting the development of insulin resistance. Standard lipids of cardiometabolic risk do not appear to be robust enough to detect short-term early changes of cardiometabolic risk in caregivers. Trial registration: ClinicalTrials.gov Identifier: NCT02257853.

Experiences of Patients After Withdrawal From Cancer Clinical Trials.

Importance: Cancer clinical trials (CCTs) provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remission. For some, a CCT may seem like their only option. Little is known about experiences of patient-participants who withdraw or are withdrawn from CCTs. Objective: To examine patient-participants' experiences during withdrawal from CCTs. Design, Setting, and Participants: This qualitative, descriptive study used a semistructured interview designed specifically for it, with open-ended and probing questions. The study took place at a National Cancer Institute-designated comprehensive cancer center affiliated with the University of Pennsylvania. The need for a sample of 20 interviewees was determined by code and meaning saturation (ie, no new themes revealed and identified themes fully elaborated). Interviews were transcribed verbatim and analyzed with a qualitative software program. Data coded with the software were refined into categories reflecting broad themes. A criterion-based sampling approach was used to select a subset of adult patients with cancer who were former CCT participants and who agreed on exit from those CCTs to a later interview about withdrawal experiences. They were contacted one by one by telephone from September 2015 through June 2019 until 20 agreed. Data analysis was completed in October 2020. Main Outcomes and Measures: Themes characterizing patient-participants' perceptions of their withdrawal experiences. Results: Respondents' mean (SD) age was 64.42 (8.49) years; 12 (63.2%) were men. Most respondents were White (18 respondents [94.7%]) and college educated (11 respondents [55.0%]). Cancer stage data were available for 17 participants, 11 of whom (64.7%) had stage IV cancer at CCT enrollment. Thirteen respondents reported withdrawal as a result of disease progression, and 5 withdrew because of adverse effects. Other reasons for withdrawal included acute illness and participant uncertainty about the reason. Analysis of interview data yielded 5 themes: posttrial prognostic awareness, goals of care discussions, emotional coping, burden of adverse effects, and professional trust and support. Subthemes included regrets or hindsight, urgency to start next treatment, and weighing benefits and burdens of treatment. Limited discussions about patient-participants' immediate posttrial care needs left many feeling that there was no clear path forward. Conclusions and Relevance: Patient-participants transitioning from a CCT described feeling intense symptoms and emotions and awareness that their life span was short and options seemed to be limited. Communication that includes attention to posttrial needs is needed throughout the CCT to help patient-participants navigate posttrial steps. Research should focus on components of responsible and ethical CCT transitions, including types and timing of discussions and who should begin these discussions with patient-participants and their families.

A Randomized Clinical Hypnosis Pilot Study: Improvements in Self-Reported Pain Impact in Adults with Sickle Cell Disease.

Sickle cell disease (SCD) is characterized by recurrent painful vasoocclusive crises. Current evidence focuses on the frequency of acute pain crises resulting in emergency department use and nonplanned inpatient hospital admissions; yet few studies focus on pain sequelae outside the healthcare system or how individuals self-manage their chronic SCD-related pain. This study investigated the feasibility of a biobehavioral intervention as an adjunct nonpharmacological therapy to assist in the self-management of chronic pain. A randomized, controlled clinical trial of hypnosis was conducted in outpatients with SCD (n = 31). Patient-reported outcomes (PROs) administered at baseline, five, and twelve weeks from both groups included pain frequency, intensity, and quality (Pain Impact Scale (PIQ) and Numerical Rating Scales); anxiety (State-Trait Anxiety Inventory), coping strategies (Coping Strategies Scale), sleep (Pittsburgh Sleep Quality Index (PSQI)), and depression (Beck Depression Inventory (BDI)). The same PROs were collected at weeks seventeen and twenty-four from the control group after the crossover. No significant group by time interaction effects were found in any of the PROs based on the repeated-measures mixed models. The PIQ and PSQI scores decreased over time in both groups. Post hoc pairwise comparisons with the Bonferroni adjustment indicated that the mean PIQ score at baseline decreased significantly by week 12 (p = 0.01) in the hypnosis group. There were no significant changes across time before and after the crossover in any of the PROs in the control group. As suggested by these findings, pain impact and sleep in individuals with SCD may be improved through guided mind-body and self-care approaches such as hypnosis.

Health Disparities in COVID-19: Addressing the Role of Social Determinants of Health in Immune System Dysfunction to Turn the Tide.

It is evident that health disparities exist during the COVID-19 pandemic, a pandemic caused by the novel coronavirus SARS-CoV-2. Underlying reasons for COVID-19 health disparities are multi-factorial. However, social determinants, including those regarding socioeconomic status, social inequalities, health behaviors, and stress, may have implications on these disparities. Exposure to one or more of these social determinants is associated with heightened inflammatory responses, particularly increases in the cytokine interleukin-6 (IL-6), as well as immune system dysfunction. Thus, an amplified effect during COVID-19 could occur, potentially resulting in vulnerable patients experiencing an intensified cytokine storm due to a hyperactive and dysfunctional immune response. Further understanding how social determinants play a mechanistic role in COVID-19 disparities could potentially help reduce health disparities overall and in future pandemics.

Yoga for systemic lupus erythematosus (SLE): Clinician experiences and qualitative perspectives from students and yoga instructors living with SLE.

Systemic lupus erythematosus (SLE) is an autoimmune disease associated with widespread inflammation and tissue damage. It is more common and severe among Blacks, Hispanics, and Asians; with higher incidence in women. While the goals of medical treatment are to prevent flares and reduce organ damage, up to 50% of patients perceive their health to be suboptimal with unaddressed needs including fatigue and pain. Recent SLE treatment guidelines focus on improving quality of life. Yoga has shown improvements in quality-of-life and fatigue in various diagnoses. While there is growing evidence that yoga therapy may help osteoarthritis and rheumatoid arthritis symptoms, there is only one reference in the literature related to SLE. METHODS/SETTING: An adjunct study was undertaken to evaluate adapting the Yoga as Self Care for Arthritis in Minority Communities study for a bilingual population living with SLE in the Washington, DC area. Informants included 7 patients enrolled onto the study, and 3 yoga instructors living with SLE. Qualitative methods included journals and semi-structured interviews. RESULTS: Enrolling patients clarified revisions for intake questionnaires, and symptoms that may impact class participation. Participants demonstrated increased balance, body awareness, and tolerated a faster-paced yoga class when compared to those in the parent study. Yoga instructors' recommendations included modifying yoga based on energy levels and frequent changes in physical ability. CONCLUSION: This paper shares perspectives from various informants and affirms the feasibility of progressing to a larger study. It summarizes our findings and recommendations towards creating a randomized controlled trial, as there are currently none in the literature.

Feasibility and assessment of outcome measures for yoga as self-care for minorities with arthritis: a pilot study.

BACKGROUND: While there is a growing interest in the therapeutic benefits of yoga, minority populations with arthritis tend to be under-represented in the research. Additionally, there is an absence of guidance in the literature regarding the use of multicultural teams and sociocultural health beliefs, when designing yoga studies for a racially diverse population with arthritis. This pilot study examined the feasibility of offering yoga as a self-care modality to an urban, bilingual, minority population with osteoarthritis (OA) or rheumatoid arthritis (RA), in the Washington, DC area. METHODS: The primary objective of the study was to assess the feasibility of offering an 8-week, bilingual yoga intervention adapted for arthritis to a convenience sample of primarily Hispanic and Black/African-American adults. A racially diverse interdisciplinary research team was assembled to design a study to facilitate recruitment and retention. The second objective identified outcome measures to operationalize potential facilitators and barriers to self-care and self-efficacy. The third objective determined the feasibility of using computer-assisted self-interview (CASI) for data collection. RESULTS: Enrolled participants (n = 30) were mostly female (93%), Spanish speaking (69%), and diagnosed with RA (88.5%). Feasibility was evaluated using practicality, acceptability, adaptation, and expansion of an arthritis-adapted yoga intervention, modified for this population. Recruitment (51%) and participation (60%) rates were similar to previous research and clinical experience with the study population. Of those enrolled, 18 started the intervention. For adherence, 12 out of 18 (67%) participants completed the intervention. All (100%), who completed the intervention, continued to practice yoga 3 months after completing the study. Using nonparametric tests, selected outcome measures showed a measurable change post-intervention suggesting appropriate use in future studies. An in-person computerized questionnaire was determined to be a feasible method of data collection. CONCLUSIONS: Findings from this pilot study confirm the feasibility of offering yoga to this racially/ethnically diverse population with arthritis. This article provides recruitment/retention rates, outcome measures with error rates, and data collection recommendations for a previously under-represented population. Suggestions include allocating resources for translation and using a multicultural design to facilitate recruitment and retention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01617421.

A qualitative approach exploring the acceptability of yoga for minorities living with arthritis: 'Where are the people who look like me?'

OBJECTIVES: To examine the acceptability of yoga research tailored to recruit and retain a minority population (both English and Spanish speaking) with arthritis. Yoga research for arthritis often underrepresents minorities and acceptability for this population has not previously been investigated. DESIGN: Acceptability was evaluated using retention, adherence, journals, and semi-structured exit interviews from twelve participants with osteoarthritis or rheumatoid arthritis undergoing an 8-week yoga intervention. Journal quotes were analyzed using content analysis techniques. NVivo software was used to organize transcripts and assemble themes. Two methods of triangulation (data and investigator) were used to overcome potential bias from a single-perspective interpretation. Exit interview comments were content analyzed using a card sort method. The study was designed with a cultural infrastructure including a multicultural research team, translators, and bilingual materials and classes, to facilitate trust and acceptability for primarily Hispanic and Black/African-American adults. SETTING: Washington, D.C. metropolitan area, USA. RESULTS: On average participants attended 10 of 16 classes, with home practice 2-3days a week. All who completed were still practicing yoga three-months later. Qualitative narrative analysis identified major themes related to facilitating factors and barriers for yoga practice, self-efficacy, and support. Participant comments indicated that offering an arthritis-based yoga intervention and using a culturally congruent research design was found to be acceptable. CONCLUSIONS: As yoga research grows, there is a need to understand and promote acceptability for typically under-represented populations. This study attempts to inform the expansion of multicultural research designed to recruit and retain those from diverse backgrounds.

A National Survey of Yoga Instructors and their Delivery of Yoga Therapy.

Yoga therapy may improve a variety of symptoms and health conditions, but little is known about how yoga therapy is being delivered in the real world. The purpose of this study was to describe the delivery of yoga therapy by yoga instructors across the U.S. In this cross-sectional survey, certified instructors were recruited from the Iyengar Yoga National Association, United States (IYNAUS) (n = 966) via an email that contained a link to an anonymous online survey that collected information on demographics, their delivery of yoga therapy, and the health conditions and symptoms seen and records kept by the instructors. A total of 487 instructors (50.4%) completed the surve y. Instructors ranged from 28 to 82 years in age (m = 56.4 ± 10.1 years) and had been teaching for 17.0 ± 10.0 years. The majority (n = 384, 81.4%) reported teaching some form of therapeutic yoga either in groups (n = 261, 55%) and/or privately (n = 340, 73.4%). All instructors (100%) reported modifying poses in their regular yoga classes for students because of health conditions or symptoms. Other than attendance, the majority (n = 255, 57.3%) reported keeping no records on their sessions. Students came to instructors for help with over 54 health conditions, most commonly musculoskeletal conditions and injuries (n = 267, 62.8%), followed by pregnancy (n = 56, 13.2%) and hypertension (n = 22, 5.2%). Nearly all (n = 373, 85.6%) reported pain to be the symptom that brought students to yoga therapy most frequently. Whereas yoga in randomized controlled trials typically is delivered to individuals in large, homogenous groups, the instructors reported that most yoga therapy is being provided individually or in small, general therapeutic classes that include a variety of health conditions. Research is needed to examine the effectiveness of yoga therapy under such conditions. A clear set of guidelines for assessing and documenting the effectiveness of yoga therapy using standardized, valid, and reliable methods is needed, particularly for pain-related conditions.

Yoga Research and Spirituality: A Case Study Discussion.

There is growing evidence that yoga can be beneficial as an aspect of self-care for people with arthritis. However, yoga may be less acceptable to those from different cultures, socioeconomic backgrounds, and racial/ethnic identities. While implementing a feasibility/acceptability pilot study of yoga as self-care in minority communities, the subject of spirituality surfaced. This commentary shares the experience of the researchers and yoga teachers collaborating on the study and the larger conversation that ensued following the withdrawal of one of the study participants. It is an attempt to start a relevant and needed dialogue around yoga research as an integrative health modality, and why the underlying body-mind-spirit approach to yoga may sometimes serve as a barrier to participation for diverse populations suffering from arthritis.

Randomized trial of hypnosis as a pain and symptom management strategy in adults with sickle cell disease.

UNLABELLED: Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00393250.

Shared decision making: a fundamental tenet in a conceptual framework of integrative healthcare delivery.

With the increased usage of complementary and alternative medicine (CAM) in the US comes a need for evidence-based and integrated care systems which encourage open communication between patients and providers. This paper introduces a conceptual framework for integrative care delivery, with shared decision making being the "connecting force" between holistic treatment and improved health outcomes for patients.

A pilot study of yoga as self-care for arthritis in minority communities.

BACKGROUND: While arthritis is the most common cause of disability, non-Hispanic blacks and Hispanics experience worse arthritis impact despite having the same or lower prevalence of arthritis compared to non-Hispanic whites. People with arthritis who exercise regularly have less pain, more energy, and improved sleep, yet arthritis is one of the most common reasons for limiting physical activity. Mind-body interventions, such as yoga, that teach stress management along with physical activity may be well suited for investigation in both osteoarthritis and rheumatoid arthritis. Yoga users are predominantly white, female, and college educated. There are few studies that examine yoga in minority populations; none address arthritis. This paper presents a study protocol examining the feasibility and acceptability of providing yoga to an urban, minority population with arthritis. METHODS/DESIGN: In this ongoing pilot study, a convenience sample of 20 minority adults diagnosed with either osteoarthritis or rheumatoid arthritis undergo an 8-week program of yoga classes. It is believed that by attending yoga classes designed for patients with arthritis, with racially concordant instructors; acceptability of yoga as an adjunct to standard arthritis treatment and self-care will be enhanced. Self-care is defined as adopting behaviors that improve physical and mental well-being. This concept is quantified through collecting patient-reported outcome measures related to spiritual growth, health responsibility, interpersonal relations, and stress management. Additional measures collected during this study include: physical function, anxiety/depression, fatigue, sleep disturbance, social roles, and pain; as well as baseline demographic and clinical data. Field notes, quantitative and qualitative data regarding feasibility and acceptability are also collected. Acceptability is determined by response/retention rates, positive qualitative data, and continuing yoga practice after three months. DISCUSSION: There are a number of challenges in recruiting and retaining participants from a community clinic serving minority populations. Adopting behaviors that improve well-being and quality of life include those that integrate mental health (mind) and physical health (body). Few studies have examined offering integrative modalities to this population. This pilot was undertaken to quantify measures of feasibility and acceptability that will be useful when evaluating future plans for expanding the study of yoga in urban, minority populations with arthritis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01617421.

Naturopathic management of females with cervical atypia: a delphi process to explore current practice.

BACKGROUND: Human papillomavirus is the most significant factor contributing to cervical cancer. Naturopathic doctors (NDs) implement an integrative approach to treat cervical atypia. This study explored practice consensus and variance among NDs. METHODS: A purposefully selected panel of six NDs participated in a modified Delphi study to validate practice. Three electronic web-based surveys were completed over nine months. RESULTS: Local and systemic treatments were included in all ND protocols. Six protocols included cervical cancer screening guidelines, green tea suppositories, and oral folic acid. Five protocols included oral green tea, diindoylemethane (DIM), and cartenoids. Four protocols incorporated Vitamin C. Two NDs considered escharotics when managing cervical atypia. All NDs included health behavior management in their protocols. CONCLUSION: Naturopathic management of cervical atypia varies across practitioners. However, in general, elements of management include (1) cervical cancer screening guidelines, (2) local and systemic treatments, (3) health behavior/lifestyle recommendations, and (4) immune system support.

To Tell or Not to Tell: Shared Decision Making, CAM Use and Disclosure Among Underserved Patients with Rheumatic Diseases.

The purpose of this analysis was to assess the impact of perceived shared decision-making (SDM) on complementary and alternative medicine (CAM) use and disclosure in a sample of urban, underserved minority patients (n = 109) with rheumatic diseases. Nearly three quarters of the patients (71.6%) reported CAM use. Of these, 59% disclosed CAM use to their provider. Logistic regression models were created. In model 1 SDM significantly predicted CAM use; however, the overall model fit was not significant. In model 2, gender, ethnicity, and SDM predicted CAM disclosure with 73.2% correctly classified. Females were more likely and Hispanics were less likely to disclose CAM use. Those with higher SDM scores were more likely to disclose CAM use. SDM played a role in whether patients used CAM and disclosed CAM use to their providers. Improving SDM strategies may be especially important among patients who are least likely to disclose CAM use.

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach.

PURPOSE: To prospectively compare outcomes and processes of hospital-based early palliative care with standard care in surgical oncology patients (N = 152). METHODS: A randomized, mixed methods, longitudinal study evaluated the effectiveness of a hospital-based Pain and Palliative Care Service (PPCS). Interviews were conducted presurgically and at follow-up visits up to 1 year. Primary outcome measures included the Gracely Pain Intensity and Unpleasantness Scales and the Symptom Distress Scale. Qualitative interviews assessed social support, satisfaction with care, and communication with providers. Survival analysis methods explored factors related to treatment crossover and study discontinuation. Models for repeated measures within subjects over time explored treatment and covariate effects on patient-reported pain and symptom distress. RESULTS: None of the estimated differences achieved statistical significance; however, for those who remained on study for 12 months, the PPCS group performed better than their standard of care counterparts. Patients identified consistent communication, emotional support, and pain and symptom management as positive contributions delivered by the PPCS. CONCLUSIONS: It is unclear whether lower pain perceptions despite greater symptom distress were clinically meaningful; however, when coupled with the patients' perceptions of their increased resources and alternatives for pain control, one begins to see the value of an integrated PPCS.

Validating English- and Spanish-language patient-reported outcome measures in underserved patients with rheumatic disease.

INTRODUCTION: Rheumatic diseases are among the most common and debilitating health problems in the United States. These diseases are chronic, can result in severe decrements of physical and psychosocial functioning and affect patients' overall quality of life. A consensus regarding the best patient outcomes to be measured in randomized, controlled trials and prospective natural history studies is essential to provide best estimates of efficacy and safety of interventions across diverse patient populations. METHODS: Face-to-face English- and Spanish-language cognitive interviews were conducted among urban Hispanic and African American patients with rheumatic disease to develop a questionnaire booklet. Six measures validating patient-reported outcomes were included: the Arthritis Self-Efficacy Scale, the Stanford Health Assessment Questionnaire Disability Index, the Wong-Baker Faces Pain Scale, the Short Acculturation Scale, the Center for Epidemiologic Studies Depression Scale and the Inventory of Complementary and Alternative Medicine Practices. A sample of patients (n = 15) attending the National Institute of Arthritis and Musculoskeletal and Skin Diseases Community Health Center participated in the initial interviews. Revised measures were further tested for reliability in a separate sample of patients (n = 109) upon enrollment at the health center. RESULTS: Cognitive interviews provided feedback for questionnaire modifications and methods to enhance content validity and data quality, including discarding redundant questions, providing visual aids and concrete examples when appropriate and increasing the use of racially and ethnically concordant interviewers. The cognitive interviews further elucidated that some contextual assumptions and language usage in the original questionnaires may not have taken each respondent's environmental and sociocultural context into consideration. Internal reliability for previously tested measures remained high (Cronbach's α = 0.87-0.94). CONCLUSIONS: Cognitive interviewing techniques are useful in a diverse sample of racial and ethnic minority patients with rheumatic disease as a method to assess the content validity of the specific outcome measures selected. The data collection approaches and methods described here ultimately enhance data quality. Vigilance is required in the selection of outcome measures in studies or in practice, particularly with each new language translation and/or culturally unique or diverse sample.