Experiences in the realisation of a research project on anthroposophical medicine in patients with advanced cancer

Questions under study: To date most of the published studies on the effecti veness of complementary therapies in cancer patients have yielded controver sial results because of questionable methodology. Research strategies and m ethodologies acceptable to both conventional and unconventional medicine ar e difficult to find due to different belief systems. In this publication we describe the development and implementation of a project conducted as part of National Research Programme 34 (NFP 34). Detailed analysis of our exper iences might provide some information on how to deal with practical difficu lties in the planning and conduct of further research projects in this fiel d. The project involved the anthroposophical Lukas Clinic in Arlesheim and the Institute of Medical Oncology of the University Hospital, Berne. This i nterdisciplinary research project was devised to study the relative merits of these two schools of medicine in the care of advanced cancer patients. T he project was made up of three components: (1) a registration study aimed at comparing the case mix at the two institutions; (2) a three armed random ised study on the effectiveness of supportive therapy, comparing anthroposo phy to psychosocial group therapy, and (3) a longitudinal study to monitor the evaluation of quality of life of patients at the anthroposophical clini c. Methods: After a brief review of the study protocol, which presents the the oretical framework of the project, problems of its implementation are descr ibed. Aspects of accrual, acceptance of randomisation and data availability are presented using simple descriptive statistics and logistic regression. Results: The registration study was duly completed with a total of 567 pati ents. For several reasons (not meeting inclusion requirements, high refusal rate) the accrual into the randomised study was slower than expected and r equired modification of the original design specifications with regard to i nclusion criteria and data collection schedule. Additionally, a high dropou t rate contributed to premature closure of this part of the project. The lo ngitudinal study also suffered from low data availability at follow up. Conclusions: The study protocol constituted a major effort at compromise wi thout loss of scientific rigour, and this effort demonstrates that it is po ssible to allow for different views on patients, on clinical interventions and on research strategies when establishing collaboration between differen t schools of medicine. Despite a theoretically sound framework, the randomi sed part of the project proved difficult in its practical execution. Some u nexpected logistical constraints and some unmet expectations influenced the feasibility of this part of the project. Therefore, careful planning of re search projects in this field of medicine should always include an extended analysis of various practical aspects of study implementation.