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)

NCT06805669 | Recruiting

• 1 other identifier: SARC-004
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

Sarcoma; Palliative Care

Outcome Measures

Primary Outcomes (1)

• To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not

  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

Study Arms (2)

Early Referral to Palliative Care

EXPERIMENTAL

Other: Early referral to palliative care

Standard Treatment

OTHER

Other: Standard Treatment

Interventions

Early referral to palliative care OTHER

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

Early Referral to Palliative Care

Standard Treatment OTHER

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

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Albiruni R. Abdul Razak

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Manager

CONTACT

416-586-8440; Oncology.Research@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 3, 2025
• Study Start: March 20, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)