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Completed

NCT Number: NCT01494883

Mindfulness for Lung Cancer Patients and Partners

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

A weekly training of eight sessions lasting two and a half hours.

Primary outcomes

  1. Change from baseline in Psychological Distress at 3 and 6 months

    Time frame: at 0, 3, 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2011
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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