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

Abstract

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

Defining the Quality of Acupuncture

“…Three studies used the Brief Fatigue Inventory (BFI), 22,24,28 including only patients with a BFI ≤4. One study used the Functional Assessment of Cancer Therapy Treatment instrument (FACIT-F) including patients scoring below <44.…”

“…To recruit patients with persistent CRF, studies sought patients who had chemotherapy at least 1 month [24][25][26][27][28] or at least 60 days prior to the trial commencement date. 22 One study did not include length of time since chemotherapy or radiotherapy.…”

“…23 Molassiotis and colleagues included patients who reported high fatigue levels >5 on a visual analogue scale (VAS) of 0 to 10. [25][26][27] The primary outcome measures used were FACIT-F, 23 BFI, 22,24,28 and the Multidimensional Fatigue Inventory (MFI). [25][26][27] Interventions were acupuncture alone, or acupuncture combined with education.…”

“…23 The type of chemotherapy was documented in all 3 Molassiotis studies and length of chemotherapy regime or radiotherapy in one study. 28 Five studies were conducted in breast cancer patients [23][24][25]27,28 the 2 other studies included a variety of tumor types.…”

“…All studies were RCTs of parallel design. Five trials had 2 study groups, [22][23][24][25][26] and 2 trials had 3 study groups. 27,28 Risk of bias assessment has been completed elsewhere for these trials.…”