Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study.

BACKGROUND: Cancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions. METHODS: We assessed the feasibility of delivering patient education integrated with acupuncture for relief of CRF in a pilot randomized controlled trial (RCT) with breast cancer survivors using usual care as control. Social cognitive and integrative medicine theories guided integration of patient education with acupuncture into a coherent treatment protocol. The intervention consisted of two parts. First, patients were taught to improve self-care by optimizing exercise routines, improving nutrition, implementing some additional evidence-based cognitive behavioral techniques such as stress management in four weekly 50-minute sessions. Second, patients received eight weekly 50-minute acupuncture sessions. The pre-specified primary outcome, CRF, was assessed with the Brief Fatigue Inventory (BFI). Secondary outcomes included three dimensions of cognitive impairment assessed with the FACT-COGv2. RESULTS: Due to difficulties in recruitment, we tried several methods that led to the development of a tailored recruitment strategy: we enlisted oncologists into the core research team and recruited patients completing treatment from oncology waiting rooms. Compared to usual care control, the intervention was associated with a 2.38-point decline in fatigue as measured by the BFI (90% Confidence Interval from 0.586 to 5.014; p <0.10). Outcomes associated with cognitive dysfunction were not statistically significant. CONCLUSIONS: Patient education integrated with acupuncture had a very promising effect that warrants conducting a larger RCT to confirm findings. An effective recruitment strategy will be essential for the successful execution of a larger-scale trial. TRIAL REGISTRATION: NCT00646633.

A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol.

BACKGROUND: Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. METHODS/DESIGN: Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. DISCUSSION: Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT01096823.

"Now I see a brighter day": expectations and perceived benefits of an Iyengar yoga intervention for young patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic disease characterized by inflammation of joints and associated fatigue, deteriorated range of motion, and impaired psychosocial functioning. Young adults with RA are at a particular risk for compromised health-related quality of life, and there is a need for safe, effective complementary treatment in addition to traditional medical approaches. The aim of the present study was to use face-to-face participant interviews, conducted before and after an Iyengar yoga (IY) program, to examine mechanisms through which yoga may be beneficial to young adults with RA.This pilot study utilized a single-arm design where all participants received the intervention. Classes were taught twice per week (1.5 hours each) for 6 weeks by an IY teacher qualified in therapeutics. Interview themes included participants' baseline expectations about yoga and viewpoints as to how their functioning had been impacted by the IY intervention were examined. Five young adults with RA aged 24-31 years (mean = 28; 80% female) completed the yoga intervention. Participants consistently reported that yoga helped with energy, relaxation and mood and they discussed perceived mechanisms for how yoga impacted well-being. Mechanisms included physical changes such as range of motion and physiological awareness, and psychospiritual developments such as acceptance, coping, self-efficacy and mindfulness. Though the study is limited, participants' responses provide compelling evidence that IY for RA patients is an intervention worthy of further exploration. The mechanisms and outcomes reported by participants support a biopsychosocial model, which proposes that yoga benefits patients through both physiological and psychospiritual changes.

Iyengar yoga for young adults with rheumatoid arthritis: results from a mixed-methods pilot study.

CONTEXT: Rheumatoid arthritis (RA) is a chronic disease that often impacts patient's quality of life. For young people with RA, there is a need for rehabilitative approaches that have been shown to be safe and to lead to improved functioning. OBJECTIVES: This pilot study investigated the feasibility of a single-arm, group-administered, six-week, biweekly Iyengar yoga (IY) program for eight young adults with RA. METHODS: IY is known for its use of props, therapeutic sequences designed for patient populations, emphasis on alignment, and a rigorous teacher training. Treatment outcomes were evaluated using a mixed-methods approach that combined quantitative results from standardized questionnaires and qualitative interviews with participants. RESULTS: Initial attrition was 37% (n=3) after the first week because of scheduling conflicts and a prior non-RA related injury. However, the remaining participants (n=5) completed between 75% and 100% of treatment sessions (mean=95%). No adverse events were reported. The quantitative results indicated significant improvements in pain, pain disability, depression, mental health, vitality, and self-efficacy. Interviews demonstrated improvement in RA symptoms and functioning but uncertainty about whether the intervention affected pain. CONCLUSION: These preliminary findings indicate that IY is a feasible complementary approach for young people with RA, although larger clinical trials are needed to demonstrate safety and efficacy.

Confronting chemobrain: an in-depth look at survivors' reports of impact on work, social networks, and health care response.

INTRODUCTION: Mild cognitive impairment following chemotherapy is one of the most commonly reported post treatment symptoms by breast cancer survivors. This deterioration in cognitive function, commonly referred to as "chemobrain" or "chemofog," was largely unacknowledged by the medical community until recent years. Although chemobrain has now become the subject of more vigorous exploration, little is known about this specific phenomenon's psychosocial impact on breast cancer survivors. This research documents in-depth the effects that cognitive impairment has on women's personal and professional lives, and our data suggest that greater attention needs to be focused on this arena of survivorship. METHODS: The results are based on an in-depth qualitative study of 74 white and African American breast cancer survivors in California who experience post-treatment side effects. The data reported herein were obtained through the use of focus groups and in-depth interviews. RESULTS: Our data indicate that cognitive impairment can be problematic for survivors, with many asserting that it is their most troublesome post treatment symptom. Survivors report diminished quality of life and daily functioning as a result of chemobrain. Respondents detail a range of coping strategies that they are forced to employ in order to manage their social and professional lives. DISCUSSIONS/CONCLUSIONS: Chemobrain significantly impairs a proportion of cancer survivors, at great cost to them economically, emotionally, and interpersonally. This suggests that more research needs to be conducted on the psychosocial ramifications of post treatment symptoms in order to inform the efforts of the medical and mental health communities as well as the support networks of survivors. IMPLICATIONS FOR CANCER SURVIVORS: A better and broader understanding of the effects of cognitive impairment both in the medical community and among lay people could pave the way for improved social and psychological services for this population.

Marketing therapeutic precision: Potential facilitators and barriers to adoption of n-of-1 trials.

BACKGROUND: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. METHODS: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. RESULTS: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. CONCLUSIONS: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients.

Harnessing experience: exploring the gap between evidence-based medicine and clinical practice.

RATIONALE, AIMS AND OBJECTIVES: There is mounting evidence of a gap between Evidence-based Medicine (EBM) and physician clinical practice, in part because EBM is averaged global evidence gathered from exogenous populations which may not be relevant to local circumstances. Local endogenous evidence, collected in particular and 'real world' patient populations may be more relevant, convincing and timely for clinical practice. Evidence Farming (EF) is a concept to provide such local evidence through the systematic collection of clinical experience to guide more effective practice. METHODS: We report on the findings of a pilot study of 29 individual and three focus group (n = 10) interviews exploring physicians' evaluations how they use multiple sources of information in clinical decision making and their thoughts on EF. RESULTS: Physicians recognize a gap in translating EBM to practice. Physicians reported that when making clinical decisions, they more often rely on clinical experience, the opinions of colleagues and EBM summarizing electronic clinical resources rather than refer directly to EBM literature. Confidence in making decisions based on clinical experience increases over time, yet few physicians reported having systems for tracking their clinical experience in designing treatment plans and patient outcomes. Most physicians saw EF as a promising way to track experience, thereby making scientific evidence more relevant to their own clinical practices. CONCLUSION: Clinical experience is relatively neglected by the EBM movement, but if that experience were systematically gathered through an approach such as EF, it would meet a need left unfulfilled by EBM.

What ever happened to N-of-1 trials? Insiders' perspectives and a look to the future.

CONTEXT: When feasible, randomized, blinded single-patient (n-of-1) trials are uniquely capable of establishing the best treatment in an individual patient. Despite early enthusiasm, by the turn of the twenty-first century, few academic centers were conducting n-of-1 trials on a regular basis. METHODS: The authors reviewed the literature and conducted in-depth telephone interviews with leaders in the n-of-1 trial movement. FINDINGS: N-of-1 trials can improve care by increasing therapeutic precision. However, they have not been widely adopted, in part because physicians do not sufficiently value the reduction in uncertainty they yield weighed against the inconvenience they impose. Limited evidence suggests that patients may be receptive to n-of-1 trials once they understand the benefits. CONCLUSIONS: N-of-1 trials offer a unique opportunity to individualize clinical care and enrich clinical research. While ongoing changes in drug discovery, manufacture, and marketing may ultimately spur pharmaceutical makers and health care payers to support n-of-1 trials, at present the most promising resuscitation strategy is stripping n-of-1 trials to their essentials and marketing them directly to patients. In order to optimize statistical inference from these trials, empirical Bayes methods can be used to combine individual patient data with aggregate data from comparable patients.