BackgroundCancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions.MethodsWe 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.ResultsDue 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.ConclusionsPatient 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 registrationNCT00646633
This study examined whether a traditional low-impact mind-body exercise, Tai Chi, affects healthrelated quality-of-life (HRQOL) and headache impact in an adult population suffering from tension-type headaches. Forty-seven participants were randomly assigned to either a 15 week intervention program of Tai Chi instruction or a wait-list control group. HRQOL (SF-36v2) and headache status (HIT-6Ô) were obtained at baseline and at 5, 10 and 15 weeks post-baseline during the intervention period. Statistically significant (P < 0.05) improvements in favor of the intervention were present for the HIT score and the SF-36 pain, energy/fatigue, social functioning, emotional well-being and mental health summary scores. A 15 week intervention of Tai Chi practice was effective in reducing headache impact and also effective in improving perceptions of some aspects of physical and mental health.
Assessing individual change is feasible and potentially useful in clinical practice. This article provides an overview of the evaluation of statistically significant change in health-related quality of life (HRQOL) for individual patients. We review the standard error of measurement, standard error of prediction, and reliable change indices using a sample of 54 patients receiving care at the UCLA Center for East-West Medicine. The largest amount of change necessary for statistical significance was found for the reliable change index and the smallest change was needed for the standard error of measurement. The amount of change required for statistical significance was intermediate for the standard error of prediction. The median kappa for classifying change (declined, stayed the same, improved) by different indices was .82, indicating a high level of agreement. Future research is needed to determine if one index is most appropriate for evaluating the significance of individual change.
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