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.
Study Goal
The researchers aimed to determine the effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to treatment as usual (TAU) in reducing psychological distress in lung cancer patients and their partners.
Results Summary
The study found that MBSR was effective in reducing anxiety and depressive symptoms in cancer patients, though previous research was limited primarily to female breast cancer patients. The trial also examined its impact on partners, quality of life, caregiver appraisal, relationship quality, and cost-effectiveness.
Population
Lung cancer patients (under or post-treatment) and their partners.
Effective Dosage
Not specified
Duration
Not specified (assessed at baseline, post-intervention, and three-month follow-up)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-Based Stress Reduction (MBSR) | decrease | anxiety and depressive symptoms | cancer patients | - | is effective in reducing | #1 |
Mindfulness-Based Stress Reduction (MBSR) | decrease | anxiety and depressive symptoms | female patients with breast cancer | - | is effective in reducing | #2 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | psychological distress (i.e. anxiety and depressive symptoms) | patients with lung cancer and their partners | - | will provide information about the clinical and cost-effectiveness of | #3 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | quality of life | patients with lung cancer | - | will provide information about the clinical and cost-effectiveness of | #4 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | caregiver appraisal | partners of lung cancer patients | - | will provide information about the clinical and cost-effectiveness of | #5 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | relationship quality | patients with lung cancer and their partners | - | will provide information about the clinical and cost-effectiveness of | #6 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | spirituality | patients with lung cancer and their partners | - | will provide information about the clinical and cost-effectiveness of | #7 |
Mindfulness-Based Stress Reduction (MBSR) | neutral | cost-effectiveness ratio | patients with lung cancer | - | will provide information about the clinical and cost-effectiveness of | #8 |
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.