To randomise or not to randomise: methodological pitfalls of the RCT design in psychosocial intervention studies.

We are seeing evidence of more studies investigating the effectiveness of psychosocial interventions of cancer patients, predominantly within groups. As roles within cancer and palliative care diversify, specially trained nurses and other health care workers are taking a more active role within psychosocial intervention studies. Frequently, these studies are randomised controlled trials (RCTs). Often, the results of these psychosocial RCTs have been laid open to general criticisms of design, implementation and reporting. The following paper focuses specifically on the general and experimenter problems in conducting RCTs within psychosocial interventions. It highlights the limitations and inherent problems seen with RCTs of psychosocial interventions so that health care workers are aware of these before considering undertaking psychosocial RCTs with cancer patients.