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
ID
Bron
Aandoening
Lung cancer - longkanker
distress - distress
anxiety - angst
depression - depressie
Ondersteuning
- RINO Zuid
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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, Büssing, 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.
Doel van het onderzoek
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
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
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 CD’s 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.
Algemeen / deelnemers
Postbus 640
6460 AP Kerkrade
I. Lux,
[default] 6460 AP
The Netherlands
045 576 6490
i.lux@atriummc.nl
Wetenschappers
Postbus 640
6460 AP Kerkrade
I. Lux,
[default] 6460 AP
The Netherlands
045 576 6490
i.lux@atriummc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- ECOG PS > 2
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4146 |
NTR-old | NTR4290 |
Ander register | Atrium Medisch Centrum : METC nummer: 13-N-161 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |