Mindfulness for Lung Cancer Patients and Partners
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.|
- Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Marital satisfaction at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Quality of Life at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Medical costs at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Mindfulness Skills at 3 and 6 months [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|No Intervention: Treatment as usual|
Experimental: Mindfulnes Based Stress Reduction
A weekly training of eight session lasting two and a half hours.
Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.
Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.
Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.
In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494883
|Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500HB|
|Principal Investigator:||Anne EM Speckens, Prof. dr.||Radboud University|
|Principal Investigator:||Miep A van der Drift, Drs.||Radboud University|
|Principal Investigator:||Judith B Prins, Prof. dr.||Radboud University|