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Open Access Highly Accessed Study protocol

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study

Melanie PJ Schellekens1*, Desiree GM van den Hurk2, Judith B Prins3, Johan Molema2, A Rogier T Donders4, Willem H Woertman4, Miep A van der Drift2 and Anne EM Speckens1

Author Affiliations

1 Department of Psychiatry, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

2 Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

3 Department of Medical Psychology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

4 Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

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BMC Cancer 2014, 14:3  doi:10.1186/1471-2407-14-3

Published: 3 January 2014

Abstract

Background

Lung 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/Design

A 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.

Discussion

This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

Trial registration

ClinicalTrials.gov NCT01494883.

Keywords:
Mindfulness-based stress reduction; Lung cancer patients; Partners; Psychological distress; Randomized controlled trial