Mindfulness for Lung Cancer Patients and Partners

This study is currently recruiting participants.
Verified March 2012 by Radboud University
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01494883
First received: December 2, 2011
Last updated: March 9, 2012
Last verified: March 2012

December 2, 2011
March 9, 2012
February 2012
August 2014   (final data collection date for primary outcome measure)
Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01494883 on ClinicalTrials.gov Archive Site
  • Change from baseline in Marital satisfaction at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Medical costs at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Mindfulness Skills at 3 and 6 months [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mindfulness for Lung Cancer Patients and Partners
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Lung Cancer
Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.
  • No Intervention: Treatment as usual
    Intervention: Behavioral: Mindfulness Based Stress Reduction
  • Experimental: Mindfulnes Based Stress Reduction
    A weekly training of eight session lasting two and a half hours.
    Intervention: Behavioral: Mindfulness Based Stress Reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
January 2015
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Melanie PJ Schellekens, MSc +31243610405 m.schellekens@psy.umcn.nl
Contact: Desirée GM van den Hurk, MANP +31611038463 d.vandenhurk@uccz.umcn.nl
Netherlands
 
NCT01494883
MFN 2011-2015
Not Provided
Radboud University
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
Radboud University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP