Cancer Clinical Trial
Official title:
A Feasibility Study of Acupuncture to Improve Quality of Life and Fatigue in Cancer Patients Undergoing Radiotherapy Treatment
Feasibility randomized controlled trial of standard care v standard care + acupuncture
administered by specially-trained therapy radiographers in patients undergoing radiotherapy.
It is a feasibility study to investigate all aspects of a future definitive randomized
controlled trial, including statistical power calculation, hence there is no primary outcome
or time point.
Mixed methods: literature review, model validity, training and mentoring of radiographers,
processes, resources, interventions, procedures, patient clinical outcomes, patient and
stakeholder qualitative outcomes
The aim of the 'Acupuncture to improve quality of life and fatigue in cancer patients
undergoing Radiotherapy Treatment' (ART) project is to investigate all aspects of the
feasibility of undertaking clinical research on acupuncture with patients having radiotherapy
at the University College Hospital (UCH) Cancer division.
The program includes an exploratory feasibility randomized controlled trial to investigate
all aspects of a future definitive randomized controlled trial, including: organizational and
procedural issues, patient group (including cancer diagnosis and stage), statistical power
calculation, primary outcome measure and time point. It is NOT intended to deliver definitive
results in terms of clinical outcomes.
ART aims to establish a platform for the investigation of integrating complementary therapy
into cancer care, between the Royal London Hospital for Integrated Medicine (RLHIM) and the
UCH cancer division. The development of a research project to investigate the use of
acupuncture, a therapy not currently provided by the cancer division, to address the key
concerns of cancer patients was the starting point. The intention is to evaluate the
feasibility of such research, not to produce definitive results.
The greatest concerns of people with cancer include anxiety, fatigue, sleep problems and pain
as a consequence of their disease and its treatment. Many patients find complementary
therapies beneficial for these problems. UCH and RLHIM are both part of the University
College London Hospital NHS Trust. The RLHIM is a specialist provider of complementary
therapies, and offers treatment to cancer patients attending for radiotherapy and
chemotherapy at UCH.
ART uses multiple methods, including a systematic review of the literature, model validity
expert consensus, a novel therapy (acupuncture) and mode of delivery (specially trained
health professionals already working in the radiotherapy department), and standard measures
of outcome, culminating in a feasibility randomized controlled clinical trial.
The research program will evaluate all involved processes, resources, interventions and
procedures. Outcomes measured included patient clinical outcomes, and the views of patients
and stakeholders.
The research team comprises the Royal London Hospital for Integrated Medicine (RLHIM)
research team, UCH Cancer Clinical Trials Unit (CCTU), a Steering Group including
representatives of all interested parties including patients, an International Scientific
Advisory Committee, an Acupuncture Expert Panel, with support from Quality Health Ltd.
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