title: 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.
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
  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.
  
  
  CONCLUSIONS
  This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.
authors.affiliation: Department of Psychiatry, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Melanie.Schellekens@radboudumc.nl.
authors.forename: Melanie P J
authors.initials: MP
authors.lastname: Schellekens
authors.forename: Desiree G M
authors.initials: DG
authors.lastname: van den Hurk
authors.forename: Judith B
authors.initials: JB
authors.lastname: Prins
authors.forename: Johan
authors.initials: J
authors.lastname: Molema
authors.forename: A Rogier T
authors.initials: AR
authors.lastname: Donders
authors.forename: Willem H
authors.initials: WH
authors.lastname: Woertman
authors.forename: Miep A
authors.initials: MA
authors.lastname: van der Drift
authors.forename: Anne E M
authors.initials: AE
authors.lastname: Speckens
mesh_terms: D001007:Anxiety / Q000191:economics / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003863:Depression / Q000191:economics / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007398:Interpersonal Relations; D008175:Lung Neoplasms / Q000150:complications / Q000191:economics / Q000523:psychology* / Q000628:therapy; D008297:Male; D064866:Mindfulness / Q000191:economics; D009426:Netherlands; D010361:Patients / Q000523:psychology*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D029181:Spirituality; D018454:Spouses / Q000523:psychology*; D013315:Stress, Psychological / Q000191:economics / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome