ISRCTN18955704已完成未知
A multicentre non-blinded randomised controlled trial to assess the impact of Regular Early SPEcialist symptom Control Treatment on quality of life in malignant Mesothelioma - 'RESPECT-Meso'
Portsmouth Hospitals NHS Trust (UK)0 个研究点目标入组 174 人开始时间: 2014年1月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 174
研究概览
简要总结
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25238873 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30661019 (added 09/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological confirmation of malignant pleural mesothelioma (MPM)
- •2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. (Asymptomatic patients score 0; symptomatic but ambulatory patients score 1)
- •3. The diagnosis of MPM received within the last 6 weeks
- •4. Ability to provide written informed consent in English and comply with trial procedures
- •5. Males and females aged 18 and over
排除标准
- •Current exclusion criteria as of 21/09/2015:
- •1. Other known malignancy within 5 years (excluding localised squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, grade III and low grade prostate cancer (Gleason score <5, with no metastases)).
- •2. Significant morbidity which the lead physician (or MDT) feel will unduly confound or influence QOL.
- •3. Those patients the MDT judge require referral to the SPCT at the point of diagnosis.
- •4. Concurrent, or less than 3 months, since participation in another non-mesothelioma clinical trial that may affect QOL.
- •5. Participation in a concurrent mesothelioma trial, within 12 weeks after randomisation, that may affect QOL.
- •6. Referral at the time of recruitment for cytoreductive, tumour de-bulking, radical decortication or extrapleural pneumonectomy surgery for MPM. (Video Assisted Thoracoscopic Surgery or ‘mini’ thoracotomy for pleurodesis and diagnosis attempts are permissible.)
- •7. Chemotherapy treatment for MPM initiated prior to consent.
- •8. A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the last 12 months.
- •Previous exclusion criteria:
- •1. Other known malignancy within 5 years (excluding localised squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, grade III and low grade prostate cancer (Gleason score <5, with no metastases).
- •2. Significant morbidity which the lead physician (or MDT) feel will unduly confound or influence quality of life (QOL).
- •3. Those patients the MDT judge require referral to the SPCT at the point of diagnosis.
- •4. Concurrent, or less than 3 months, since participation in another clinical trial that may affect QOL.
- •5. Referral at the time of recruitment for cytoreductive, tumour de-bulking, radical decortication or extrapleural pneumonectomy surgery for MPM (Video Assisted Thoracoscopic Surgery or ?mini? thoracotomy for pleurodesis and diagnosis attempts are permissible)
- •6. Chemotherapy treatment for MPM initiated prior to consent.
- •7. A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the last 12 months.
研究者
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