- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380651
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage
Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Tampere, Finland
- Tampere university Hospital
-
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Uusimaa
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Helsinki, Uusimaa, Finland, 00029
- Helsinki University Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
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6 months to five years
|
Collaborators and Investigators
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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