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Mindfulness for Lung Cancer Patients and Partners

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ClinicalTrials.gov Identifier: NCT01494883
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Lung Cancer Behavioral: Mindfulness Based Stress Reduction

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
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
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in Marital satisfaction at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
  2. Change from baseline in Quality of Life at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
  3. Change from baseline in Medical costs at 3 and 6 months [ Time Frame: at 0, 3, 6 months ]
  4. Change from baseline in Mindfulness Skills at 3 and 6 months [ Time Frame: 0, 3, 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01494883     History of Changes
Other Study ID Numbers: MFN 2011-2015
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Radboud University:
Mindfulness Based Stress Reduction
lung cancer
psychological distress

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases