Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points. MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
Barts Health NHS Trust
London, Whitechapel, United Kingdom
RECRUITINGThe Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
RECRUITINGNorth Bristol Trust
Bristol, United Kingdom
RECRUITINGPapworth
Cambridge, United Kingdom
RECRUITINGColchester
Colchester, United Kingdom
RECRUITINGDerby
Derby, United Kingdom
RECRUITINGBeatson West of Scotland Cancer Centre
Glasgow, United Kingdom
RECRUITINGGolden Jubilee National Hospital
Glasgow, United Kingdom
NOT_YET_RECRUITINGLeeds
Leeds, United Kingdom
RECRUITINGUniversity Hospitals of Leicester NHS Trust
Leicester, United Kingdom
RECRUITING...and 15 more locations
Survival
The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.
Time frame: 24 months
Progression free survival to two years
Time frame: 24 months
Serious adverse health events to two years after randomisation
Time frame: 24 months
Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years
* 3 types of scales. Functioning scales which include physical functioning, role functioning, emotional function, cognitive functioning and social functioning. Symptom scales which include fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. An overall global health status/QoL * All scales range between 0 and 100. * For functioning scales, a high score indicates a high level of functioning. Similarly, a high global health status/QoL score indicates a high quality of life. For symptom scales, a high score indicates a high level of symptoms.
Time frame: 24 months
Resource and health service use to two years and during initial surgical admission for surgical arm
Time frame: 24 months and during initial surgical admission for surgical arm
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
* subscales: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. These range from 1-5. * subscales mobility, self-care, usual activities, pain/discomfort, anxiety/depression are combined to calculate an overall index score which ranges from -0.59 to 1. * A higher score indicates better quality of life
Time frame: 24 Months
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
* VAS (visual analogue scale) score. Ranges from 0 to 100. * A higher score indicates better quality of life
Time frame: 24 months
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