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

Sponsor
Institut Cancerologie de l'Ouest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04644913
Collaborator
(none)
300
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quality of life questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-term Evaluation of the Quality of Life and the Functional Repercussions of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Study the concordance of scores from the quality of life questionnaires: SF 36 and TESS [12 months]

    Scoring of questionnaires SF36 and TESS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients from the French FCCSS or COHOPER or SALTO cohorts 2) Adult patient (> 18 years old) when filling out the study questionnaires 3) Patient treated for a bone tumor before the age of 18 4) Patient with a minimum follow-up of 5 years without cancer treatment (treated before 2014) 5) Patient living in France and speaking French
Exclusion Criteria:
  1. Patient with a 2nd cancer

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Cancerologie de l'Ouest

Investigators

  • Study Director: Stéphane SUPIOT, PHD-MD, ICO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT04644913
Other Study ID Numbers:
  • ICO
First Posted:
Nov 25, 2020
Last Update Posted:
Nov 25, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Cancerologie de l'Ouest
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2020