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.

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.

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.