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

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.

A Pilot Mobile-Based Mindfulness Intervention for Cancer Patients and Their Informal Caregivers

“…Second, our study is one of the few mindfulness intervention studies that also included patients' informal caregivers (Birnie, Garland, & Carlson, 2010; Schellekens et al, 2014; Schellekens et al, 2017; van den Hurk, Schellekens, Molema, Speckens, & van der Drift, 2015). As the number of individuals living with cancer increases, from 14 million in 2012 to a projected 18 million by 2022, the number of informal caregivers will grow in parallel (de Moor et al, 2013).…”

A review on cost-effectiveness and cost-utility of psychosocial care in cancer patients

“…[27] This reflects the fast-growing number of studies that are conducted on the cost-effectiveness or cost-utility of psychosocial care. In addition, several protocol papers of currently ongoing studies were identified,[9454647484950] which will provide new evidence on the cost-effectiveness or cost-utility of psychosocial care in the coming years.…”

Mindfulness‐based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial

“…Following CONSORT guidelines, we conducted a multicentre, parallel‐group, RCT comparing CAU + MBSR with CAU. The trial protocol has been published previously and received approval by the local medical ethics committee (CMO Arnhem‐Nijmegen, 2011‐519).…”

“…Participants received teachings on stress and grief and were invited to share their experiences. For more details, see study protocol . Three formally trained MBSR teachers fulfilling the advanced criteria of the Center for Mindfulness of the University of Massachusetts Medical School ran 9 MBSR groups in total with on average 9 participants per group (consisting of both study participants and patients with other cancer types).…”

“…Assessments took place at baseline (T0), post intervention (T1), and 3‐month post T1 (T2). See study protocol for further details . Information about patients' frequency and nature of health care use during the intervention period was collected via monthly self‐reported health care diaries.…”