This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)

Not Applicable

Recruiting

• Conditions: Sarcoma

• Registration Number: NCT06805669
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.

Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Primary Completion: 2027-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Signed written and voluntary informed consent.
• Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
• Age ≥ 18 years.
• Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
• Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• Life expectancy > 6 months.
• Willing/able to complete questionnaires.

Exclusion Criteria

• Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
• Patient in need of urgent home support services or symptom management through a palliative care team.
• Patient is being actively followed by a palliative care physician.
• Active psychiatric disorder or drug abuse.
• Insufficient English literacy to complete questionnaires.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not	From enrollment/baseline to 12 weeks	HRQoL will be assessed using ESAS-r (Edmonton Symptom Assessment System - revised) and EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C-30).

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada