Mindfulness for Lung Cancer Patients and Partners

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Mindfulness Based Stress Reduction

• Registration Number: NCT01494883
• Lead Sponsor: Radboud University Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Study Start: 2012-02
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulnes Based Stress Reduction	Mindfulness Based Stress Reduction	A weekly training of eight session lasting two and a half hours.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Psychological Distress at 3 and 6 months	at 0, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Quality of Life at 3 and 6 months	at 0, 3, 6 months
Change from baseline in Medical costs at 3 and 6 months	at 0, 3, 6 months
Change from baseline in Marital satisfaction at 3 and 6 months	at 0, 3, 6 months
Change from baseline in Mindfulness Skills at 3 and 6 months	0, 3, 6 months

Trial Locations

Locations (1)

Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands