Mindfulness for Lung Cancer Patients and Partners

September 9, 2015 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Anne EM Speckens, Prof. dr., Radboud University Medical Center
  • Principal Investigator: Miep A van der Drift, Drs., Radboud University Medical Center
  • Principal Investigator: Judith B Prins, Prof. dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFN 2011-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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