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

April 9, 2018 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with soft tissue sarcoma with metastatic lung disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Palliative Surgery Group
Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt to proceed with palliative surgical treatment
Non-surgical Group
Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt not to pursue palliative surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

August 7, 2017

Study Completion (ACTUAL)

August 7, 2017

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (ESTIMATE)

March 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00044852

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Soft Tissue Sarcoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe