Mindfulness for Lung Cancer Patients and Partners

Study Overview
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Brief Summary
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The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.

Detailed Description
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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.

Official Title
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Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer. Patients can participate after lung cancer diagnosis, from start of treatment or after treatment. Sufficient understanding of Dutch language. Exclusion Criteria: Former participation in MBSR or MBCT course. Current psychological treatment by psychologist or psychiatrist. Cognitive impairments hampering participation in MBSR and completion of questionnaires. Physical impairments prohibiting participation in MBSR training.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br> | |
| Experimental: Mindfulnes Based Stress Reduction<br>A weekly training of eight session lasting two and a half hours. | Behavioral: Mindfulness Based Stress Reduction<br>* A weekly training of eight sessions lasting two and a half hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Psychological Distress at 3 and 6 months |  | at 0, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Marital satisfaction at 3 and 6 months |  | at 0, 3, 6 months | 
| Change from baseline in Quality of Life at 3 and 6 months |  | at 0, 3, 6 months | 
| Change from baseline in Medical costs at 3 and 6 months |  | at 0, 3, 6 months | 
| Change from baseline in Mindfulness Skills at 3 and 6 months |  | 0, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Stress Reduction, lung cancer, psychological distress, caretakers