Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

January 15, 2021 updated by: Jussi Repo, Helsinki University Central Hospital

Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study

This study aims to:

  1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
  2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.

Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.

The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.

Study Type

Observational

Enrollment (Actual)

141

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

  • Finland
    • Helsinki And Uusimaa
      • Helsinki, Helsinki And Uusimaa, Finland, 00029
        • Cancer center, Helsinki University Hospital and University of Helsinki

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lower extremity sarcoma patient who underwent limb-salvage surgery

Description

Inclusion Criteria:

  • Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot
  • No metastasis at the time of diagnosis
  • Undergone limb salvage surgery
  • A minimum of 1 year follow-up
  • Written consent
  • Age > 18

Exclusion Criteria:

  • Age <18
  • No limb-salvage surgery due to sarcoma

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
Time Frame: two to five years
The validity is studied
two to five years
Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
Time Frame: two to five years
The test-retest reliability is studied
two to five years
Health-related quality of life after limb salvage
Time Frame: two to five years
Assessment of health-related quality of life
two to five years
Assessment of the functional ability after limb salvage
Time Frame: two to five years
Assessment of functional ability
two to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Questionnaire-Core 30
Time Frame: two to five years
Health-related quality of life assessment
two to five years
The 15-dimensions health-related quality of life instrument
Time Frame: two to five years
Health-related quality of life assessment
two to five years
The Musculoskeletal Tumor Society score lower extremity section
Time Frame: two to five years
Functional assessment of the reconstructed limb
two to five years
The Toronto Extremity Salvage Score lower extremity section
Time Frame: two to five years
Functional assessment of the reconstructed limb
two to five years

Collaborators and Investigators

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

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Carl Blomqvist, MD, PhD, Helsinki University Hospital and University of Helsinki

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

December 1, 2015

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 324/13/03/02/2014/2

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.

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