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

NCT ID: NCT02080897

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Sarcoma Metastatic Lung Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Palliative Surgery Group

Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt to proceed with palliative surgical treatment

No interventions assigned to this group

Non-surgical Group

Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt not to pursue palliative surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Eward, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00044852

Identifier Type: -

Identifier Source: org_study_id

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