A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer

Original Research Protocol, Copenhagen January 2007 Cancer and Mindfulness: A prospective, randomized trial of a psychosocial intervention among women operated for breast cancer

Background From the time of diagnosis cancer patients have a need for psychological support. Many patients handle the situation by the help of friends and family, while others need professional support to come to terms with different phases of life as a cancer patient. Only few randomized trials have been conducted in order to determine what kinds of professional support patients will benefit from. These studies conclude that the prevalence of anxiety and depression in reduced. This is of major importance as depending of cancer type, treatment modality, age and gender, a total of 10-50 % of Danish cancer patients reports such well-defined psychosocial symptoms following the diagnosis of cancer.

Mindfulness meditation aims to increase the experience of presence and an increased relation to several emotional and sensory experiences. Instead of being a technique aimed to control and change unwanted psychological states the method is rather a way to stay present in the here and now without judging and as such it has been developed into a stress reduction method: mindfulness based stress reduction (MBSR). The method is taught within a group setting by an instructor guiding the patients during a week long program. The method has been evaluated within a variety of settings and has been found to effectively reduce symptoms related to different stress and pain conditions i.e. psoriasis, chronic pain, HIV/AIDS, anxiety and depression.2 Based on these experiences several programs have been developed and the program developed by Williams and Kabatt-Zinn has gained status as the most commonly applied and best validated. Within recent years the program has been included into cognitive-behavioral therapy. But with potential effects not only as reduction of symptoms but further opens the opportunity for participants to approach spiritual and existential themes. The potential effect is therefore not limited to simple reduction of symptoms but includes increased meaningfulness, quality of life and sense of coherence.

Nine studies of the effect of MBSR haw been conducted, including 10- 157 adult cancer patients being taught MBSR in groups of mainly breast cancer patients, but only three of these trials have been conducted as randomized controlled trials. I these trials patients have self-referred (selection bias), analysis have not been adjusted for biological status of the cancer disease (confounding), samples have been small (n=10-157) (type 2 error) and patients have differed with regard to time since diagnosis (misclassification). Despite these methodological limitations a tendency of positive effects of MBSR participation on psychological and physiological outcomes has been observed.

Yet it is still not determined whether MBSR will provide cancer patients benefit improving their daily life with cancer. Some important aspects have not been addressed in previous studies: When MBSR is applied as an intervention dose-response relation has only been observed among patients with a moderate level of symptoms. Thus sensitivity of MBSR in relation to stages of cancer, levels of pain or negative effects of treatments. We still do not know whether all cancer patients will profit from this type of intervention. Further the influence of patient compliance and working alliance is still not explored.