Clinical trial NCT02536053: Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage
Official title: Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Salvage
Keywords: [E04.100.814.603]
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 141
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lower extremity sarcoma patient who underwent limb-salvage surgery

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
timeFrame: two to five years
measure: Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
timeFrame: two to five years
measure: Health-related quality of life after limb salvage
timeFrame: two to five years
measure: Assessment of the functional ability after limb salvage
timeFrame: two to five years
Secondary outcomes:
measure: Quality of Life Questionnaire-Core 30
timeFrame: two to five years
measure: The 15-dimensions health-related quality of life instrument
timeFrame: two to five years
measure: The Musculoskeletal Tumor Society score lower extremity section
timeFrame: two to five years
measure: The Toronto Extremity Salvage Score lower extremity section
timeFrame: two to five years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Cancer center, Helsinki University Hospital and University of Helsinki
state: Helsinki And Uusimaa
Study officials:
affiliation: Helsinki University Hospital and University of Helsinki
name: Erkki J Tukiainen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Hospital and University of Helsinki
name: Carl Blomqvist, MD, PhD
role: STUDY_DIRECTOR
References: