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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who underwent limb salvage surgery for bone or soft tissue sarcoma of the lower extremity at UZ Leuven

18 to 95 years old

Patients should be at least one year post surgery

Informed consent has obtained

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional outcome

    Other intervention

    3D-motion analysis and strength assessment

  • Health related quality of life (HRQoL) assessment

    Other intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Soft tissue sarcoma of the thighOther 2 interventions
Group B: Control groupNo intervention 0 interventions
Group C: Bone or soft tissue sarcoma of the lower extremityOther 1 intervention

Trial outcomes

Primary outcomes

1

Musculoskeletal Tumor Society Score (MSTS)

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

Time frame
Within a period of 1 year
2

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

To measure cancer patients' physical, psychological and social functions

Time frame
Within a period of 1 year
3

Participation and Autonomy Questionnaire Questionnaire (IPAQ)

To measure health-related physical activity

Time frame
Within a period of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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