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Recruiting

NCT Number: NCT06805669

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)

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early referral to palliative care

Other

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

standard treatment

Other

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

Primary outcomes

  1. 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).

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

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

Acronym: SARQUALITY

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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