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NCT Number: NCT02380651

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

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.

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Key information

Conditions

Cancer of Muscle Muscle Neoplasms Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Soft Tissue Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital, Helsinki, Uusimaa, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limb salvage

Procedure

Local or free flaps

Primary outcomes

  1. 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

Secondary outcomes

  1. Sarcoma recurrence

    Time frame: 6 months to five years

    to assess sarcoma recurrence

  2. Quality of Life Questionnaire-Core 30

    Time frame: 6 months to five years

    to assess the health-related quality of life

  3. the 15D health-related quality of life instrument

    Time frame: 6 months to five years

    to assess the health-related quality of life

  4. The QuickDASH

    Time frame: 6 months to five years

    to assess the upper-extremity function

  5. The MSTS upper extremity section

    Time frame: 6 months to five years

    to assess the upper-extremity function

  6. The TESS upper extremity section

    Time frame: 6 months to five years

    to assess the upper-extremity function

Other outcomes

  1. Visual Analogue Scale for pain

    Time frame: 6 months to five years

    to assess pain

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2015
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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