Effecten van Mindfulness Based Stress Reduction (MBSR) bij mensen met longkanker.|
|- candidate number||15779|
|- NTR Number||NTR4290|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-nov-2013|
|- Secondary IDs||METC nummer: 13-N-161 Atrium Medisch Centrum|
|- Public Title||Effecten van Mindfulness Based Stress Reduction (MBSR) bij mensen met longkanker.|
|- Scientific Title||Effect of Mindfulness Based Stress Reduction on distress, anxiety and depression in patients with lung cancer.|
|- hypothesis||1. MBSR will reduce symptoms of distress, anxiety and depression |
2. MBSR will reduce fatigue, pain and sleep disturbance
3. MBSR will improve coping with cancer
|- Healt Condition(s) or Problem(s) studied||Lung cancer, Anxiety, Depression|
|- Inclusion criteria||- Age > 18|
- Diagnosis: lung cancer
- ECOG PS max. 2
- Fluent in expression and comprehension of the Dutch language
- motivated to complete the MBSR and daily practice at home.
|- Exclusion criteria||- ECOG PS > 2
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||31-dec-2016|
|- Target number of participants||50|
|- Interventions||The intervention, MBSR, is based on the original protocol as described by J. Kabat-Zinn (1990). The group consists of minimal five participants and maximum 15 participants. For eight following weeks participants will receive a two and a half hour training and one meditation day. They are asked to exercise at least six times a week for approximately 45 minutes. Participants will receive a workbook with written information concerning the MBSR per session and four CDís containing the home exercises.
The current study is a semi-experimental prospective between subjects design. The current study is an expansion of a previous study at the Atrium MC concerning patients with lung cancer. In the previous study participants were followed during chemotherapy and three months after chemotherapy to explore possible changes in distress, anxiety, depression and coping with cancer. The participants in the previous study will be used as a control group for the current intervention group. |
|- Primary outcome||1. Symptoms of distress, anxiety and depression. Measured with : Distress Thermometer combined with the Problem List ( DT; PL) and the Hospital Anxiety and Depression Scale (HADS).
|- Secondary outcome||1. Prevalence of fatigue, pain and sleep disturbance. Measured with: Screening Inventory for Psychosocial Problems (SIPP) and weightloss. |
2. Copingstyle. Measured with: Mental Adjustment to Cancer scale (MAC-scale)
3. Subjective burden of fatigue, pain and sleep disturbance. Measured with: three items using a seven-point Likert scale.
4. Quality of life (QoL): within the experimental group Q0L will be measured using the Dutch version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) including the specific module for Lung Cancer (QLQ-LC13)
|- Timepoints||T0: last chemotherapy; EORTC QLQ-C30 and QLQ-LC13; DT; PL; SIPP; HADS; MAC-Scale;FFMQ-SF;Subjective burden questions|
T1: after MBSR; EORTC QLQ-C30 and QLQ-LC13; DT; PL; SIPP; HADS; MAC-Scale;FFMQ-SF;Subjective burden questions
T2: 4 wks after MBSR: EORTC QLQ-C30 and QLQ-LC13; DT; PL; SIPP; HADS; MAC-Scale;FFMQ-SF;Subjective burden questions
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Msc. I. Lux,|
|- CONTACT for SCIENTIFIC QUERIES||Msc. I. Lux,|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Atrium Medical Center, Heerlen|
|- Brief summary||Lung cancer is the most lethal and common cancer around the world (Parkin, Bray & Devesa, 2001; Jemal, Siegel, Ward, Hao & Xu, 2009). Patients with lung cancer have more physical complaints and a shorter survival rate compared to other cancer types. The five year survival rate is 16% in Europe (Cooley, 2000; Janssen-Heijnen & Coeberg, 2003). Besides the physical burden, research further shows that patients with lung cancer experience a higher degree of psychological burden or distress compared to other cancer populations (Li & Girgis, 2006; Carlson, Angen, Cullum et al., 2004; Sellick & Edwardson, 2007).
Since psychological complaints such as distress, anxiety and depression were reduced and QoL was improved by MBSR in studies with mixed patient populations and mixed cancer groups, MBSR might have the same positive results in lung cancer patients (Bear, 2003; Smith, Richardson, Hoffman & Pilkington, 2005; Carlson & Garland, 2005; Ott, Norris & Bauer-Wu, 2006; Matchim & Armer, 2007; Ledesma & Kumano, 2009; Shennan, Payne & Fenlon, 2011; Musial, BŁssing, Heusser, Choi & Ostermann, 2011).
Considering the evidence for positive effects of MBSR on some of the core physical components of lung cancer, e.g. fatigue, pain and sleep disturbance (Carlson & Garland, 2005; Marchand, 2012), it seems critically important to assess whether patients with lung cancer can also achieve a reduction of their physical and psychological burden.
The current study is a semi-experimental prospective between subjects design. The current study is an expansion of a previous study at the Atrium MC concerning patients with lung cancer. In the previous study participants were followed during chemotherapy and three months after chemotherapy to explore possible changes in distress, anxiety, depression and coping with cancer. In the absence of an intervention, no significant changes in symptoms of distress, anxiety and depression were found. Participants with high levels of distress, anxiety and depression before chemotherapy, continued to have high levels of distress, anxiety and depression three months after chemo. The participants in the previous study will be used as a control group for the current intervention group. All participants will receive standard medical care during the study. |
|- Main changes (audit trail)|
|- RECORD||28-nov-2013 - 2-feb-2014|
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