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 studyReportar como inadecuado




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BMC Cancer

, 14:3

Epidemiology, prevention and public health

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.

KeywordsMindfulness-based stress reduction Lung cancer patients Partners Psychological distress Randomized controlled trial AbbreviationsMBSRMindfulness-based stress reduction

RCTRandomized controlled trial

RUNMCRadboud University Nijmegen Medical Centre

MBCTMindfulness-based cognitive therapy

MMSEMini mental state examination

DTDistress thermometer

HADSHospital anxiety and depression scale

QLQ-C30Quality of life – cancer

QLQ-LC13Quality of life – lung cancer

SIPSickness impact profile

SPPICSelf-perceived pressure from informal care

CRA-SECaregiver reaction assessment – care-derived self-esteem

IMS-SInvestment model scale-satisfaction

MISMutuality and interpersonal sensitivity

SAILSpiritual attitude and involvement list

FFMQFive facet mindfulness questionnaire

SCSSelf-compassion scale

RRS-EXTRumination response scale – extended version

IESImpact of event scale.

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Autor: Melanie PJ Schellekens - Desiree GM van den Hurk - Judith B Prins - Johan Molema - A Rogier T Donders - Willem H Woert

Fuente: https://link.springer.com/







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