Mindfulness for Lung Cancer Patients and Partners

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494883
• Other study ID #: MFN 2011-2015
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: September 9, 2015
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Psychological Distress at 3 and 6 months		at 0, 3, 6 months
Secondary	Change from baseline in Marital satisfaction at 3 and 6 months		at 0, 3, 6 months
Secondary	Change from baseline in Quality of Life at 3 and 6 months		at 0, 3, 6 months
Secondary	Change from baseline in Medical costs at 3 and 6 months		at 0, 3, 6 months
Secondary	Change from baseline in Mindfulness Skills at 3 and 6 months		0, 3, 6 months