Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080897
• Other study ID #: Pro00044852
• Status: Completed
• First received: March 5, 2014
• Last updated: April 9, 2018
• Start date: March 2014
• Est. completion date: August 7, 2017

Study information

• Verified date: April 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Metastatic Lung Disease
• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QoL score using patient-response questionnaire	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.	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)