Abstract
BackgroundLung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners.Methods/DesignA parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed.DiscussionThis trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.Trial registrationClinicalTrials.gov NCT01494883.
Highlights
Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis
This trial will provide information about the clinical and cost-effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to treatment as usual (TAU) in patients with lung cancer and their partners
The aim of the Mindfulness for Lung Oncology Nijmegen (MILON) study is to examine the effectiveness of MBSR compared to TAU in reducing psychological distress in patients with lung cancer and their partners
Summary
In the last ten years MBSR has proven to be a feasible and acceptable intervention in cancer patients [76], but it seems to be effective in reducing psychological distress [30]. The generalization of these results is limited because most participants were female. Authors’ contributions All authors contributed to the design of the study. AS, MD and JP are the principal investigators of the study. MS drafted the paper, which was modified and supplemented by all other authors. DH, MS and MD are involved in recruiting participants while MS and DH take care of the logistics of the study and data collection. RD contributed to the statistical analysis plan and WW contributed to the design of the costeffectiveness evaluation. All authors read and approved the final manuscript
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