Mindfulness for Lung Cancer Patients and Partners
|ClinicalTrials.gov Identifier: NCT01494883|
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : September 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Behavioral: Mindfulness Based Stress Reduction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
|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.
- Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
- Change from baseline in Marital satisfaction at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
- Change from baseline in Quality of Life at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
- Change from baseline in Medical costs at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
- Change from baseline in Mindfulness Skills at 3 and 6 months [ Time Frame: 0, 3, 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|