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Clinical Trials/NCT02080897
NCT02080897
Completed
N/A

Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease Using the ESAS-Sarcoma Modified Questionnaire

Duke University1 site in 1 country4 target enrollmentMarch 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Soft Tissue Sarcoma
Sponsor
Duke University
Enrollment
4
Locations
1
Primary Endpoint
Change in QoL score using patient-response questionnaire
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for resection of the primary tumour will be compared to those that are unable to have surgery. Data collected from this questionnaire can highlight the benefits in patients' QoL who receive palliative surgical resection, and whether these benefits surmount those who are not treated with palliative surgery.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 7, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with soft tissue sarcoma with at least one pulmonary metastasis
  • Metastatic lung disease must have been present at time of initial presentation

Exclusion Criteria

  • All patients under 18 will be excluded
  • Patients who have been previously undergone surgical resection of the primary tumor

Outcomes

Primary Outcomes

Change in QoL score using patient-response questionnaire

Time Frame: questionnaire will be obtained at initial presentation and at up to 7 additional visits (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months after initial presentation or treatment)

The Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire will be completed at baseline, 6 weeks and 3, 6, 12, 24, 36 and 60 months post presentation/surgical intervention.

Study Sites (1)

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