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Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients (QOL Sarcoma)

Primary Purpose

Soft Tissue Sarcoma, Bone Sarcoma

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Functional outcome
Health related quality of life (HRQoL) assessment
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft Tissue Sarcoma focused on measuring Lower extremities, Health related quality of life, Functional outcome, Limb salvage surgery

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

No Intervention

Other

Arm Label

Soft tissue sarcoma of the thigh

Control group

Bone or soft tissue sarcoma of the lower extremity

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Musculoskeletal Tumor Society Score (MSTS)
To determine the physical and mental health for patients with extremity sarcoma
Quality of Life Questionnaire C-30 (QLQ-C30)
To measure cancer patients' physical, psychological and social functions
Participation and Autonomy Questionnaire Questionnaire (IPAQ)
To measure health-related physical activity

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
October 15, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05051059
Brief Title
Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients
Acronym
QOL Sarcoma
Official Title
Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. There have been dramatic improvements in the survival rate of sarcoma patients in the past 40 years owing to increasing effectiveness of chemotherapy. This, along with developments in imaging techniques, have led to earlier diagnosis and more accurate preoperative staging. It is estimated that there are nearly 50,000 survivors of bone and soft tissue sarcomas in the United States. 70% of those are younger than the age of 50 years. Whilst traditional treatment for bone tumors used to be amputation, advances in surgical techniques have made limb-salvage procedures a valid alternative method of treatment in 80-85% of patients with primary bone sarcomas. 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. There are few reports available in the literature on the quality of life in sarcoma survivors. It was found that elderly patients, retired patients, and those who live alone need more intensive psychological care. Female patients were found to cope poorly with their disease compared to male gender. It was also found that the physical status greatly influences the overall outcome and quality of life in this group of patients. This stresses the importance of enrolment in tailored rehabilitation programs. 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. In literature, the gait pattern after endoprosthetic replacement around the knee joint was studied and found that, despite decreased walking velocity, stride length, and stance phase of the operated limb, these patients still have a symmetrical gait. Also in another report, an electromyographic assessment of gait after bone sarcoma surgery about the knee showed prolonged activation of rectus femoris and hamstring muscles in the affected limb compared to a control group. Other researchers found that limb-salvage patients often adopt a "stiff-legged" gait pattern. These findings are of utmost importance for the development of efficient rehabilitation programs for these patients. 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. Researchers investigated the knee extension strength and postoperative functional outcome after quadriceps resection for soft tissue sarcoma of the thigh. They found that knee extension strength decreased when the number of resected quadriceps increased and this was associated with lower functional scores. They concluded that good functional results can be expected if at least two quadriceps muscles are preserved. However, no detailed assessment of gait in this group of patients has been published.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Bone Sarcoma
Keywords
Lower extremities, Health related quality of life, Functional outcome, Limb salvage surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue sarcoma of the thigh
Arm Type
Other
Arm Description
Patients who underwent surgical resection of a deep intramuscular soft tissue sarcoma of the thigh
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Bone or soft tissue sarcoma of the lower extremity
Arm Type
Other
Arm Description
Patients who underwent surgical resection of a bone or soft tissue sarcoma of the lower extremity
Intervention Type
Other
Intervention Name(s)
Functional outcome
Intervention Description
3D-motion analysis and strength assessment
Intervention Type
Other
Intervention Name(s)
Health related quality of life (HRQoL) assessment
Intervention Description
Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)
Primary Outcome Measure Information:
Title
Musculoskeletal Tumor Society Score (MSTS)
Description
To determine the physical and mental health for patients with extremity sarcoma
Time Frame
Within a period of 1 year
Title
Quality of Life Questionnaire C-30 (QLQ-C30)
Description
To measure cancer patients' physical, psychological and social functions
Time Frame
Within a period of 1 year
Title
Participation and Autonomy Questionnaire Questionnaire (IPAQ)
Description
To measure health-related physical activity
Time Frame
Within a period of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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