Mindfulness for Lung Cancer Patients and Partners

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Lung Cancer
Behavioral: Mindfulness Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494883

Contacts
Contact: Melanie PJ Schellekens, MSc +31243610405 m.schellekens@psy.umcn.nl
Contact: Desirée GM van den Hurk, MANP +31611038463 d.vandenhurk@uccz.umcn.nl

Locations
Netherlands
Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Investigators
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

No publications provided by Radboud University

Additional 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
Study First Received: December 2, 2011
Last Updated: March 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on October 01, 2014