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

NCT04644913 | Completed

• 1 other identifier: ICO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteosarcoma in Children

Keywords

Quality of life; Long term follow up; Orthopedic surgery; Radiotherapy

Outcome Measures

Primary Outcomes (1)

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

  Scoring of questionnaires SF36 and TESS

  12 months

Interventions

Quality of life questionnaire BEHAVIORAL

Sending of 2 questionnaires (SF 36 and TESS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The PAIR Pediatrics 2017 START project is interested in adults treated for a tumor or malignant hemopathy before the age of 18, in France, since 1980, and with a minimum follow-up of 5 years without cancer treatment. The START-os study sample will select patients with at least 5 years of follow-up after childhood sarcoma treated by surgery with or without radiotherapy from the French Childhood Cancer Registry (FCCSS cohorts (patients treated before 2000), COHOPER (patients treated since 2000) and SALTO (patients diagnosed between 1987 and 1992)).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Canérologie de l'Ouest

Angers, 49055, France

Location

Study Officials

• Stéphane SUPIOT, PHD-MD

  ICO

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: November 18, 2022
• Primary Completion: January 29, 2023
• Study Completion: January 29, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)