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PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.
- Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma.
- Determine whether the nodules that develop after radiotherapy are symptomatic in these patients.
- Compare the quality of life of patients treated with radiotherapy vs standard care alone.
OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed.
- Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months.
Patients are followed at 1, 2, 4, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.
Primary Purpose: Treatment
quality-of-life assessment, standard follow-up care, radiation therapy
Gartnavel General Hospitall
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:25-0400
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Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
A nursing specialty concerned with care of patients facing serious or life-threatening illnesses. The goal of palliative nursing is to prevent and relieve suffering, and to support the best possible quality of life for patients and their families. Hospice nursing is palliative care for people in their final stages of life.
Component of the NATIONAL INSTITUTES OF HEALTH. It conducts and supports clinical and basic research to establish a scientific basis for the care of individuals across the life span, from the management of patients during illness and recovery to the reduction of risks for disease and disability; the promotion of healthy lifestyles; the promotion of quality of life in those with chronic illness; and the care for individuals at the end of life. It was established in 1986.
Evaluation procedures that focus on both the outcome or status (OUTCOMES ASSESSMENT) of the patient at the end of an episode of care - presence of symptoms, level of activity, and mortality; and the process (ASSESSMENT, PROCESS) - what is done for the patient diagnostically and therapeutically.
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