Johnston, M. F., Hays, R. D., Subramanian, S. K., Elashoff, R. M., Axe, E. K., Li, J. J., . . . Hui, K. K. (2011). Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complementary and Alternative Medicine, 11, 49.

This small pilot study had two objectives:  (1) to design a strategy for recruitment tailored to the institutional environment and therapeutic intervention and (2) to collect evidence of preliminary effects.

In a two-part intervention, patients were first taught to improve self-care with regard to exercise, nutrition, and cognitive-behavioral techniques over a four-week period. They were then provided with eight weekly 50-minute acupuncture sessions. This therapeutic protocol references a conceptual framework derived from two theories—Social Cognitive Theory and Integrative Medicine Theory—but did not provide a description of the theory to match the interventions (exercise, nutrition, cognitive therapy, or acupuncture) with conceptual variables in the model.

• The sample was comprised of 13 women with breast cancer.   
• Mean age was 54 years (range 18–65). 
• About two-thirds of the patients were white.

• Single site  
• University of California Los Angeles Center for East-West Medicine
   

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

This was a randomized, controlled feasibility study.

• Brief Fatigue Inventory (BFI) to assess cancer-related fatigue (self-reported)
• Functional Assessment of Cancer Therapy–Cognitive Function, version 2 (FACT-COGv2) to measure three dimensions of perceived cognitive impairment:  cognitive problems, impact on functioning, and impact on health-related quality of life (self-assessment without objective measures)

Failure of the recruitment methods led to the development of a tailored recruitment strategy. The intervention was said to be associated with a 2.38-point decline in fatigue (BFI) (90% confidence interval [0.586, 5.014]; p < 0.10). Differences in perceived cognitive dysfunction outcomes were not statistically significant between the two groups over time. The authors talked about using a pooled standard deviation for the BFI at baseline to compare the means of the two groups to determine the effect size.

An effective recruitment strategy is necessary for the execution of any randomized, controlled trial. The conceptual framework integrating social cognitive theory and integrative medicine was not effectively operationalized.

• The pooled standard deviation was not reported. It was unclear how the Cohen’s D metric was applied to this small study.
• The study had a small sample size, with less than 30 patients; 13 patients were randomized of 40 recruited.
• The study had a poor design.
• Numerous confounding variables were not controlled for in the first part of the intervention in which patients were taught to improve self-care by optimizing exercise routines, improving nutrition, and implementing various cognitive-behavioral techniques.
• The tailored recruitment strategy of two two-hour recruitment sessions is labor intensive to yield only 5 interested patients.
• One patient assigned to the control group actually received acupuncture and patient education, but his/her results were calculated with the control group.
• The study was nonblinded.

Investigation into outcomes attributed to specific patient education interventions might first be warranted before blending such an educational intervention with a complimentary/alternative therapy studying efficacy on cancer-related fatigue.