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

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.

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Key information

Conditions

Soft Tissue Sarcoma Lung Diseases Metastatic Lung Disease Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Respiratory Tract Diseases Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Mar 7, 2014
Registry last updated: Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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