Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage

Cancer of Muscle Clinical Trial

Official title:

Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380651
• Other study ID #: 324/13/03/02/2014/1
• Status: Completed
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: January 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Muscle
• Sarcoma

Intervention

Procedure:
• Limb salvage
Local or free flaps

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale for pain	to assess pain	6 months to five years
Primary	Health-related quality of life and upper-extremity functional capability	To assess health-related quality of life and upper-extremity functional capability	6 months to five years
Secondary	Sarcoma recurrence	to assess sarcoma recurrence	6 months to five years
Secondary	Quality of Life Questionnaire-Core 30	to assess the health-related quality of life	6 months to five years
Secondary	the 15D health-related quality of life instrument	to assess the health-related quality of life	6 months to five years
Secondary	The QuickDASH	to assess the upper-extremity function	6 months to five years
Secondary	The MSTS upper extremity section	to assess the upper-extremity function	6 months to five years
Secondary	The TESS upper extremity section	to assess the upper-extremity function	6 months to five years