Ensuring model validity in a feasibility study of acupuncture to improve quality of life in cancer patients undergoing radiotherapy treatment

Abstract

IntroductionA feasibility study of acupuncture for quality of life in cancer patients is planned. The pragmatic randomised controlled trial will aim to assess the feasibility of training radiographers to administer acupuncture to their patients undergoing radiotherapy intended to cure their cancer. The preliminary phase covered in this paper aimed to develop the trial acupuncture intervention and ensure its model validity. MethodsA mixed methods approach will be adopted. Systematic review conducted examining the treatments administered in papers reporting acupuncture treatment for cancer patients. Subsequently, one-day workshop held with an acupuncture expert panel. Informed by the systematic review and their clinical expertise the expert panel devised and agreed the trial acupuncture intervention. ResultsThe acupuncture expert panel came to a consensus on the trial acupuncture intervention. Trial radiographers will treat patients for 30 min, with needles inserted for approximately 20 min of this time. The trial will employ a standard treatment protocol for constitutional symptoms (fatigue, hot flushes, mood problems, anxiety, depression, and sleep problems) consisting of non traditional ASAD (anxiety, sickness and dyspnoea) acupoints, LI4, LR3, SP6 and ST36. Additional acupoints can be utilised for nausea/vomiting and pain. Guidelines on safe practice were also agreed. ConclusionsFew clinical trials of acupuncture, and complementary medicine interventions generally, document details of the process by which they ensured the model validity of their trial intervention. It is recommended that researchers in acupuncture, and other forms of complementary medicine, adopt appropriate methodological approaches to ensure model validity.