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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02080897

Enrollment

Registered

2014-03-07

Start date

2014-03-31

Completion date

2017-08-07

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Lung Disease, Soft Tissue Sarcoma

Keywords

non-surgical, palliative surgery

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in QoL score using patient-response questionnaire	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.

Countries

United States

Outcome results