Functional Outcomes and HRQoL in Upper-extremity 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 Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study

This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.

Patient hospital records are retrospectively reviewed for demographic and clinical data.

The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.

Study Type

Observational

Enrollment (Actual)

55

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
      • Tampere, Finland
        • Tampere University Hospital
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsinki University Central Hospital

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Upper extremity sarcoma patient who underwent limb-salvage surgery

Description

Inclusion Criteria:

  • Upper extremity soft tissue sarcoma locating in between scapula to arm
  • No metastasis at the time of diagnosis
  • Undergone limb salvage surgery
  • A minimum of 6 months follow-up
  • Written consent
  • Age > 18

Exclusion Criteria:

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

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
Health-related quality of life and upper-extremity functional capability
Time Frame: 6 months to five years
To assess health-related quality of life and upper-extremity functional capability
6 months to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcoma recurrence
Time Frame: 6 months to five years
to assess sarcoma recurrence
6 months to five years
Quality of Life Questionnaire-Core 30
Time Frame: 6 months to five years
to assess the health-related quality of life
6 months to five years
the 15D health-related quality of life instrument
Time Frame: 6 months to five years
to assess the health-related quality of life
6 months to five years
The QuickDASH
Time Frame: 6 months to five years
to assess the upper-extremity function
6 months to five years
The MSTS upper extremity section
Time Frame: 6 months to five years
to assess the upper-extremity function
6 months to five years
The TESS upper extremity section
Time Frame: 6 months to five years
to assess the upper-extremity function
6 months to five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for pain
Time Frame: 6 months to five years
to assess pain
6 months to five years

Collaborators and Investigators

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

Sponsor

Helsinki University Central Hospital

Collaborators

Tampere University Hospital

Investigators

  • Study Director: Erkki J Tukiainen, MD, PhD, Helsinki University Central Hospital
  • Study Director: Carl Blomqvist, MD, PhD, Helsinki University Central Hospital

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)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 324/13/03/02/2014/1

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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