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)

Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06805669

Acronym

SARQUALITY

Enrollment

136

Registered

2025-02-03

Start date

2024-03-20

Completion date

2027-10-31

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

Sarcoma, Palliative Care

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.

Interventions

OTHEREarly referral to palliative care

Participant will be referred to palliative care at start of systemic treatment

OTHERStandard Treatment

Participants will be referred to palliative care upon appearance of uncontrollable symptoms.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Canada

Contacts

Primary ContactClinical Trials Manager

Oncology.Research@sinaihealth.ca416-586-8440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026