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) (SARQUALITY)

January 28, 2025 updated by: Mount Sinai Hospital, Canada

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Albiruni R. Abdul Razak
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Referral to Palliative Care
Other: Early referral to palliative care
Participant will be referred to palliative care at start of systemic treatment
Other: Standard Treatment
Other: Standard Treatment
Participants will be referred to palliative care upon appearance of uncontrollable symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
Time Frame: 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).
From enrollment/baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Albiruni R. Abdul Razak, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARC-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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