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 P. J. Schellekens, Desiree G M Van den Hurk, Judith Prins, Johan Molema, A Rogier T Donders, Willem H Woertman, Miep A Van der Drift, Anne E. M. Speckens
BMC cancer January 3, 2014 DOI: 10.1186/1471-2407-14-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Population | Lung cancer patients who have received or are still under treatment, and their partners |
| Intervention | Mindfulness-Based Stress Reduction (MBSR) |
| Duration | Assessments at baseline, post intervention, and three-month follow-up |
| Topics | Anxiety Depression Meditation |
| Keywords | Humans Lung neoplasms Treatment outcome Clinical protocols Stress, psychological Spouses Interpersonal relations Spirituality Research design Time factors Quality of life Patients Cost-benefit analysis Health care costs Netherlands Female Surveys and questionnaires |
| Key findings | The protocol proposes a parallel-group randomized controlled trial to test whether Mindfulness-Based Stress Reduction, compared with treatment as usual, reduces psychological distress in lung cancer patients and their partners, with assessments at baseline, post-intervention, and three-month follow-up. The authors argue this is needed because prior MBSR evidence comes mainly from female breast cancer patients and partners have rarely been studied. |
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 7
- The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients Cancer Management and Research June 1, 2015
- Mindfulness-Based Interventions for Survivors of Lung Cancer and Their Partners: A Systematic Review. International Journal of Behavioral Medicine October 2023
- Efficacy of Mindfulness-Based Cognitive Therapy and Cognitive Behavioral Therapy for Anxiety, Depression, and Fatigue in Cancer Patients: A Randomized Clinical Trial. Iranian Journal of Psychiatry July 2021
- Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. Psycho-Oncology December 2017
- Mindfulness-based stress reduction for breast cancer patients: a mixed method study on what patients experience as a suitable stage to participate. Supportive Care in Cancer October 2017
and 2 more in the library
Cites 8
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Journal of Consulting and Clinical Psychology 2000
- Competence in Teaching Mindfulness-Based Courses: Concepts, Development and Assessment Mindfulness September 21, 2011
- Psychological benefits for cancer patients and their partners participating in mindfulness‐based stress reduction (MBSR) Psycho-Oncology November 16, 2009
- The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychological Medicine May 2012
and 3 more in the library