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Completed

NCT Number: NCT04644913

Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

Surgery and radiation therapy play a major role in the treatment of bone and soft tissue tumors. Osteosarcomas, rhabdomyosarcomas, and Ewing tumors are the most common histologic types. Surgery may require multiple techniques and radiation therapy may be conformational, or more recently IMRT (Intensity Modulated Radiation Therapy). If surgery is possible, lower limb surgery is generally the recommended treatment, even if a poor functional result can be expected.

The literature is very poor regarding the impact of radiotherapy on quality of life and functional results, mainly with the use of prosthetic materials.

Tools such as the Toronto Extremity Salvage Score (TESS) are now available for self-assessment of functional outcomes. The presence of large cohorts such as FCCSS, COHOPER and SALTO facilitates these studies.

The SF-36 is a short 36-question health questionnaire that consists of a generic, consistent, and easy-to-administer set of measures. These measures are based on self-report by patients and are now widely used by organizations managing the care of adult patients.

The TESS Functional Questionnaire is a patient-completed self-questionnaire widely used for motor stimulation in patients with musculoskeletal tumors. This score is based on the definitions of handicap, impairment and handicap as documented by the World Health Organization (WHO). It includes 30 questions assessing overall function and daily activities. The final score varies from 0% to 100%, 100% being the best possible score. So far, several studies have reported the validation of TESS in Portuguese, Danish, Korean, Japanese and since this year in French. Indeed, the TESS questionnaire was validated in French by the study "Transcultural validation of TESS and MSTS questionnaires" promoted by the Nantes University Hospital.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Canérologie de l'Ouest

Angers, 49055, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients from the French FCCSS or COHOPER or SALTO cohorts Adult patient (> 18 years old) when filling out the study questionnaires Patient treated for a bone tumor before the age of 18 Patient with a minimum follow-up of 5 years without cancer treatment (treated before 2014) Patient living in France and speaking French

Exclusion criteria

Patient with a 2nd cancer Patient who has already been approached by the Hospital de NANTES as part of the cross-cultural validation of the TESS questionnaire

Treatment and study plan

Quality of Life Questionnaire

Behavioral

Sending of 2 questionnaires (SF 36 and TESS)

Primary outcomes

  1. The concordance of scores from the quality of life questionnaires: SF 36 and TESS

    Time frame: 12 months

    Scoring of questionnaires SF36 and TESS

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

Long-term Evaluation of the Quality of Life and the Functional Repercussions of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

Acronym: STARTos

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2020
Registry last updated
Aug 2, 2023

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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