Clinical trial NCT01494883: Mindfulness for Lung Cancer Patients and Partners
Official title: Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Mindfulness Based Stress Reduction
lung cancer
psychological distress
caretakers
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2011-12-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in Psychological Distress at 3 and 6 months
timeFrame: at 0, 3, 6 months
Secondary outcomes:
measure: Change from baseline in Marital satisfaction at 3 and 6 months
timeFrame: at 0, 3, 6 months
measure: Change from baseline in Quality of Life at 3 and 6 months
timeFrame: at 0, 3, 6 months
measure: Change from baseline in Medical costs at 3 and 6 months
timeFrame: at 0, 3, 6 months
measure: Change from baseline in Mindfulness Skills at 3 and 6 months
timeFrame: 0, 3, 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Anne EM Speckens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Miep A van der Drift, Drs.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Judith B Prins, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schellekens MP, van den Hurk DG, Prins JB, Molema J, Donders AR, Woertman WH, van der Drift MA, Speckens AE. Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study. BMC Cancer. 2014 Jan 3;14:3. doi: 10.1186/1471-2407-14-3.