Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients

NCT05051059 | Recruiting

• 1 other identifier: S63146
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations. In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family. Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb.

Conditions

Bone Sarcoma; Soft Tissue Sarcoma

Keywords

Lower extremities; Health related quality of life; Functional outcome; Limb salvage surgery

Outcome Measures

Primary Outcomes (3)

• Musculoskeletal Tumor Society Score (MSTS)

  To determine the physical and mental health for patients with extremity sarcoma

  Within a period of 1 year

• Quality of Life Questionnaire C-30 (QLQ-C30)

  To measure cancer patients' physical, psychological and social functions

  Within a period of 1 year

• Participation and Autonomy Questionnaire Questionnaire (IPAQ)

  To measure health-related physical activity

  Within a period of 1 year

Study Arms (3)

Soft tissue sarcoma of the thigh

OTHER

Patients who underwent surgical resection of a deep intramuscular soft tissue sarcoma of the thigh

Other: Functional outcome; Other: Health related quality of life (HRQoL) assessment

Control group

NO INTERVENTION

A group of healthy age-matched individuals will be identified out of an available gait lab database to compare the gait pattern with tha of the patient group

Bone or soft tissue sarcoma of the lower extremity

OTHER

Patients who underwent surgical resection of a bone or soft tissue sarcoma of the lower extremity

Other: Health related quality of life (HRQoL) assessment

Interventions

Health related quality of life (HRQoL) assessment OTHER

Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)

Bone or soft tissue sarcoma of the lower extremity; Soft tissue sarcoma of the thigh

Functional outcome OTHER

3D-motion analysis and strength assessment

Soft tissue sarcoma of the thigh

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent limb salvage surgery for bone or soft tissue sarcoma of the lower extremity at UZ Leuven
• to 95 years old
• Patients should be at least one year post surgery
• Informed consent has obtained

You may not qualify if:

• Patients who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
• Skeletally immature individuals
• No informed consent has obtained

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Interventions

Quality of Life; Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Hazem Wafa

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem Wafa

CONTACT

+32 16 33 88 73; hazem.wafa@uzleuven.be

Moke Lieven

CONTACT

+32 16 34 08 84; lieven.moke@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 21, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)