Mindfulness for Lung Cancer Patients and Partners
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| First Received Date ICMJE | December 2, 2011 | ||||||||||||
| Last Updated Date | March 9, 2012 | ||||||||||||
| Start Date ICMJE | February 2012 | ||||||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01494883 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Mindfulness for Lung Cancer Patients and Partners | ||||||||||||
| Official Title ICMJE | Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial. | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Lung Cancer | ||||||||||||
| Intervention ICMJE | Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 220 | ||||||||||||
| Estimated Completion Date | January 2015 | ||||||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01494883 | ||||||||||||
| Other Study ID Numbers ICMJE | MFN 2011-2015 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Radboud University | ||||||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||||||
| Collaborators ICMJE | Dutch Cancer Society | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||||||
| Verification Date | March 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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