- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-related quality of life and upper-extremity functional capability
Tidsramme: 6 months to five years
|
To assess health-related quality of life and upper-extremity functional capability
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6 months to five years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sarcoma recurrence
Tidsramme: 6 months to five years
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to assess sarcoma recurrence
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6 months to five years
|
|
Quality of Life Questionnaire-Core 30
Tidsramme: 6 months to five years
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to assess the health-related quality of life
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6 months to five years
|
|
the 15D health-related quality of life instrument
Tidsramme: 6 months to five years
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to assess the health-related quality of life
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6 months to five years
|
|
The QuickDASH
Tidsramme: 6 months to five years
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to assess the upper-extremity function
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6 months to five years
|
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The MSTS upper extremity section
Tidsramme: 6 months to five years
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to assess the upper-extremity function
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6 months to five years
|
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The TESS upper extremity section
Tidsramme: 6 months to five years
|
to assess the upper-extremity function
|
6 months to five years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale for pain
Tidsramme: 6 months to five years
|
to assess pain
|
6 months to five years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Erkki J Tukiainen, MD, PhD, Helsinki University Central Hospital
- Studieleder: Carl Blomqvist, MD, PhD, Helsinki University Central Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 324/13/03/02/2014/1
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