Mindfulness based stress reduction (MBSR) for patients with lung cancer and their partners: a randomised controlled trial.

The results of a recent meta-analysis of ten randomized controlled trials and
observational studies (Ledesma & Kumano, 2009) suggest that mindfulness may
improve cancer patients* psychosocial adjustment to their disease and enhance
their coping and well-being. A systematic review of twelve further studies
(Shennan et al., 2010) reports significant improvements in anxiety, depression,
stress and sexual difficulties. The reviews highlight the need for more
randomized controlled trials and a more diverse participant base. They also
note the need for exploring the underlying mechanisms of mindfulness and
expanding outcomes to include quality of life.

Based on the available evidence, the current study would be the first
randomized controlled trial of MBSR for cancer patients in the Netherlands. 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. Only one earlier study has
involved partners of patients (Birnie et al., 2009), although partners also
experience many psychological challenges.

Our primary hypothesis is that in patients with lung cancer MBSR might result
in a decrease of psychological distress. Secondary outcome measures will
include worry, mindfulness skills, marital satisfaction, quality of life and
medical costs. Partners of patients with lung cancer might also report less
psychological distress and worry, more mindfulness skills and marital
satisfaction and might experience less negative consequences as a caregiver.

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.

The design of the study is a randomised controlled trial, comparing an 8-week
MBSR training with a treatment as usual condition.

The difference between groups on the contrast between baseline and follow-up
will be assessed with multivariate repeated-measures analyses of covariance
with baseline and follow-up scores as dependent variables. To determine whether
increases in mindfulness or decreases in worry were responsible for the
changes, subsequent mediation analyses will be conducted (Baron & Kenny, 1986).

The MBSR course will consist of 8 sessions of 2,5 hours each and a silent day.
The structure of the course will be based on the original program developed by
Kabat-Zinn (1990) and his colleagues at the Stress Reduction and Relaxation
Clinic, Massachesetts Medical Center. Each MBSR group will consist of about 7
patients and 7 partners. The instructors of the MBSR courses will be qualified
health professionals and mindfulness trainers, maintaining a personal
meditation practice.

N/A